Form FDA 3670 FDA 3670 MedSun

MedSun Database Screenshots
April 2020

Contents
MedSun Login Page ................................................................................................................................................................. 3
Home Page .............................................................................................................................................................................. 3
“Browse/Edit” Page with Browse dropdown options ............................................................................................................. 4
View Report............................................................................................................................................................................. 5
Adverse Event Report............................................................................................................................................................. 6
Edit Report OMB Statement ............................................................................................................................................... 6
Edit Report Navigation ........................................................................................................................................................ 7
Edit Set Report Status ......................................................................................................................................................... 7
Edit Report Submit .............................................................................................................................................................. 7
Contact Info ........................................................................................................................................................................ 8
Edit/Add Report “Contact Infor” ..................................................................................................................................... 8
Add Report Contact with Facility Dropdown .................................................................................................................. 9
Event ................................................................................................................................................................................. 10
Edit/Add Report “Event” ............................................................................................................................................... 10
Add Report Event with Network Pick (used by few sites)............................................................................................. 12
Add Report Event Follow Up Where2 ........................................................................................................................... 12
Add Report Event Follow Up Other Location ................................................................................................................ 13
Add Report Event Follow Up Death .............................................................................................................................. 13
Add Report Event Follow Up Serious Injury .................................................................................................................. 14
Add Report Event Follow Up Device Problem .............................................................................................................. 14
Add Report Event Follow Up Operating Device ............................................................................................................ 15
Add Report Event Follow Up Other Therapies .............................................................................................................. 15
Add Report Event Follow Up Dialysis ............................................................................................................................ 16
Add Report Event Follow Up Chemotherapy ................................................................................................................ 16
Edit Report Submit Missing Event................................................................................................................................. 16
Patient............................................................................................................................................................................... 17
Edit/Add Report “Patient List” Empty ........................................................................................................................... 17
Edit/Add Report “Patient List” Empty ........................................................................................................................... 17
Edit/Add Report “Patient” ............................................................................................................................................ 18
Add Report Patient Pick DOB ........................................................................................................................................ 20
Add Report Patient Follow Up Allergies........................................................................................................................ 20
Add Report Patient Follow Up Relevant accidents ....................................................................................................... 21
Add Report Patient Follow Up Other ............................................................................................................................ 21
Edit Report Submit Missing Patient .............................................................................................................................. 21
Device ............................................................................................................................................................................... 22

Edit/Add Report “Device List” Empty............................................................................................................................ 22
Edit/Add Report “Device List” ....................................................................................................................................... 22
Edit/Add Report “Device” ............................................................................................................................................. 24
Add Report Device GUDID Parse................................................................................................................................... 25
Add Report Device GUDID Query.................................................................................................................................. 25
Add Report Device Follow Up Reprocessor .................................................................................................................. 26
Add Report Device Follow Up LabDevice_1 .................................................................................................................. 27
Add Report Device Follow Up LabDevice_2 .................................................................................................................. 27
Add Report Device Follow Up LabDevice_3 .................................................................................................................. 27
Add Report Device Follow Up MfrReturnDate.............................................................................................................. 28
Add Report Device Follow Up MfrReturn ..................................................................................................................... 28
Add Report Device Follow Up MfrResponse ................................................................................................................. 29
Add Report Device Follow Up MfrNoReturn................................................................................................................. 29
Edit Report Submit Missing Device ............................................................................................................................... 30
Save Options ..................................................................................................................................................................... 30
Edit Report Save Continue ............................................................................................................................................ 30
Edit Report Save Continue Ready To Submit ................................................................................................................ 30
Edit Report Save Exit Without Status ............................................................................................................................ 31
Edit Report Save Exit ..................................................................................................................................................... 31
Edit Report Save Exit Popup .......................................................................................................................................... 32
Edit Report Submit Confirmation.................................................................................................................................. 32
Test.................................................................................................................................................................................... 33
Add Report Test List Empty ........................................................................................................................................... 33
Add Report Test List ...................................................................................................................................................... 33
Add Report Test ............................................................................................................................................................ 34
Attachment ....................................................................................................................................................................... 34
Edit/Add Report “Attachment List” Empty ................................................................................................................... 34
Edit/Add Report “Attachment List” .............................................................................................................................. 35
Edit/Add Report “Attachment List” Success ................................................................................................................. 35
Analysis ............................................................................................................................................................................. 36
Analysis Tools ................................................................................................................................................................ 36
Analysis Tool Report Facility ......................................................................................................................................... 37
Analysis Tool Report Event ........................................................................................................................................... 38
Analysis Tool Report Device .......................................................................................................................................... 40
Messages .......................................................................................................................................................................... 41
Message List .................................................................................................................................................................. 41
New Message Topic ...................................................................................................................................................... 42
pg. 1

4/3/2020

New Message Topic Pick Report ................................................................................................................................... 42
Message New Topic After Pick Report .......................................................................................................................... 43
Message New Topic Post .............................................................................................................................................. 43
Message View Topic Message....................................................................................................................................... 44
Password........................................................................................................................................................................... 44
Password Reset ............................................................................................................................................................. 45
BioMed ............................................................................................................................................................................. 45
BioMed Upload Select Facility ...................................................................................................................................... 46
BioMed Upload Detail Success...................................................................................................................................... 47
BioMed Upload Fail ....................................................................................................................................................... 48
BioMed Upload Fail Detail ............................................................................................................................................ 49
BioMed Upload Loading ................................................................................................................................................ 50
Import ............................................................................................................................................................................... 50
Import ........................................................................................................................................................................... 50
Resources .......................................................................................................................................................................... 51

pg. 2

4/3/2020

MedSun Login Page

Home Page

pg. 3

4/3/2020

“Browse/Edit” Page with Browse dropdown options

pg. 4

4/3/2020

View Report

pg. 5

4/3/2020

Adverse Event Report
Edit Report OMB Statement

pg. 6

4/3/2020

Edit Report Navigation

Edit Set Report Status

Edit Report Submit

pg. 7

4/3/2020

Contact Info
Edit/Add Report “Contact Infor”

pg. 8

4/3/2020

Add Report Contact with Facility Dropdown

pg. 9

4/3/2020

Event
Edit/Add Report “Event”

pg. 10

4/3/2020

pg. 11

4/3/2020

Add Report Event with Network Pick (used by few sites)

Add Report Event Follow Up Where2

pg. 12

4/3/2020

Add Report Event Follow Up Other Location

Add Report Event Follow Up Death

pg. 13

4/3/2020

Add Report Event Follow Up Serious Injury

Add Report Event Follow Up Device Problem

pg. 14

4/3/2020

Add Report Event Follow Up Operating Device

Add Report Event Follow Up Other Therapies

pg. 15

4/3/2020

Add Report Event Follow Up Dialysis

Add Report Event Follow Up Chemotherapy

Edit Report Submit Missing Event

pg. 16

4/3/2020

Patient
Edit/Add Report “Patient List” Empty

Edit/Add Report “Patient List” Empty

pg. 17

4/3/2020

Edit/Add Report “Patient”

pg. 18

4/3/2020

pg. 19

4/3/2020

Add Report Patient Pick DOB

Add Report Patient Follow Up Allergies

pg. 20

4/3/2020

Add Report Patient Follow Up Relevant accidents

Add Report Patient Follow Up Other

Edit Report Submit Missing Patient

pg. 21

4/3/2020

Device
Edit/Add Report “Device List” Empty

Edit/Add Report “Device List”

pg. 22

4/3/2020

pg. 23

4/3/2020

Edit/Add Report “Device”

pg. 24

4/3/2020

Add Report Device GUDID Parse

Add Report Device GUDID Query

pg. 25

4/3/2020

Add Report Device Follow Up Reprocessor

pg. 26

4/3/2020

Add Report Device Follow Up LabDevice_1

Add Report Device Follow Up LabDevice_2

Add Report Device Follow Up LabDevice_3

pg. 27

4/3/2020

Add Report Device Follow Up MfrReturnDate

Add Report Device Follow Up MfrReturn

pg. 28

4/3/2020

Add Report Device Follow Up MfrResponse

Add Report Device Follow Up MfrNoReturn

pg. 29

4/3/2020

Edit Report Submit Missing Device

Save Options
Edit Report Save Continue

Edit Report Save Continue Ready To Submit

pg. 30

4/3/2020

Edit Report Save Exit Without Status

Edit Report Save Exit

pg. 31

4/3/2020

Edit Report Save Exit Popup

Edit Report Submit Confirmation

pg. 32

4/3/2020

Test
Add Report Test List Empty

Add Report Test List

pg. 33

4/3/2020

Add Report Test

Attachment
Edit/Add Report “Attachment List” Empty

pg. 34

4/3/2020

Edit/Add Report “Attachment List”

Edit/Add Report “Attachment List” Success

pg. 35

4/3/2020

Analysis
Analysis Tools

pg. 36

4/3/2020

Analysis Tool Report Facility

pg. 37

4/3/2020

Analysis Tool Report Event

pg. 38

4/3/2020

Analysis Tool Report Event Type Results

pg. 39

4/3/2020

Analysis Tool Report Device

pg. 40

4/3/2020

Messages
Message List

pg. 41

4/3/2020

New Message Topic

New Message Topic Pick Report

pg. 42

4/3/2020

Message New Topic After Pick Report

Message New Topic Post

pg. 43

4/3/2020

Message View Topic Message

Password

pg. 44

4/3/2020

Password Reset

BioMed

pg. 45

4/3/2020

BioMed Upload Select Facility

pg. 46

4/3/2020

BioMed Upload Detail Success

pg. 47

4/3/2020

BioMed Upload Fail

pg. 48

4/3/2020

BioMed Upload Fail Detail

pg. 49

4/3/2020

BioMed Upload Loading

Import
Import

pg. 50

4/3/2020

Resources

pg. 51

4/3/2020