Form FDA Form 3670 FDA Form 3670 Medsun Submission

FDA Form 3670

OMB 0910-0471

Exp. Date 12/31/2010

USection 1: Contact Information

User Facility Name:
Address:
Contact’s Name:
Contact’s Phone #:
Contact’s Fax #:
Contact’s email address:
Contact’s Occupation:
Name of initial reporter:
Address of initial reporter:

USection 2: Event Information

Event Title: (to help you identify this event)
When did the event happen? (mm/dd/yyyy)
How many days ago did you first become aware of the event?
 Less than or equal to 10 days
 More than 10 days ago
Date of this report: (mm/dd/yyyy)

USection 2: Event Information (continued)U

Where did this event occur:
 Ambulatory surgical facility			 Nursing home			 Not known
 Home			 Outpatient diagnostic facility			 Not applicable
 Hospital			 Outpatient treatment facility			 Physician’s office
 NICU			 PICU			 Other: (specify)
	If you checked “Hospital,” where in the hospital did this event occur?
	 Critical Care		 OR			 Not known
	 ER		 Skilled nursing unit			 Not applicable
	 Patient room		 Other: (specify)
The device(s) may have caused or contributed to: (check all that apply)
 Death date: (mm/dd/yyyy)			 Potential for patient harm (indicates voluntary report)
 Serious injury			 Potential harm to a health care provider (indicates voluntary report)
 Minor injury to the patient or health care provider (indicates voluntary report)			 Not known
			 Not applicable
	If you checked “Serious injury,” please answer the following questions:
	Was intervention required to prevent permanent impairment or damage?
	 Yes		 Not known
	 No		 Not applicable
	Outcomes attributed to serious injury: (check all that apply)
	 Congenital anomaly		 Life threatening
	 Disability		 Not known
	 Hospitalization, initial or prolonged		 Not applicable
	 Other: (please describe the outcome)

USection 2: Event Information (continued)

	Was there a problem with the device? (such as a defect, malfunction, break, etc.)
	 Yes					 Not known
	 No					 Not applicable
			If you checked “Yes,” what problem did the user have? (check all that apply)
			 Device failed (broke, couldn’t get it to work, stopped working, etc.)		 Not known
			 Device malfunction (the device did not do what it was supposed to do)		 Not applicable
			 Device was hard to use		 Other: (specify)
	Was someone directly “operating” the device at the time of the event?
	 Yes					 Not known
	 No					 Not applicable
			If you checked “Yes,” who was operating the device? (check all that apply)
			 Allied Health Provider		 Patient
			 Doctor		 Not known
			 Family member/visitor		 Not applicable
			 Nurse		 Other: (specify-NO NAMES)
	Were there other devices being used on the patient at the time of the event that may have caused or contributed to the event?
	Were there other therapies being used on the patient at the time of the event that may have caused or contributed to the event? (check all that apply)
	 Cardiac drugs				 Chemotherapy—date: (mm/dd/yyyy)
	 Immunotherapy				 Dialysis—date: (mm/dd/yyyy)
	 Long-term antibiotics				 Hormonal Replacement Therapy
	 Prenatal medication				 Not known
	 No other therapies				 Not applicable
	 Other: (list other therapies)

U

Section 2: Event Information (continued)U

	Describe the event or problem. Please provide as much detail as possible.

USection 2: Event Information (continued)U

What was the original intended procedure?
What was the health professional’s impression of how the device may have caused or contributed to the adverse event?

Can the health professional’s impression be included in the event?

 Yes

 No

USection 3: Patient Information U

PLEASE USE A SEPARATE PAGE FOR EACH PERSON INVOLVED

	Patient Identifier: (use something that will help you remember who the patient is. DO NOT USE the patient's name, initials, SSN, date of birth, medical record number of other identifiers) 8 Character Limit.
	Patient’s age:
	 Years
	 Months					 Do not know
	 Weeks					 Not applicable
	 Days
	Patient’s sex:
	 Male					 Not known
	 Female					 Not applicable
	Patient’s weight:
	 Pounds					 Kilograms
	 Ounces					 Grams
	 Do not know					 Not applicable
	Patient’s ethnic background: [Optional]
	 American Indian or Alaskan Native
	 Asian
	 Black or African American
	 Hispanic or Latino
	 Native Hawaiian or other Pacific Islander
	 White
	 Unknown
	 Not applicable

USection 3: Patient Information (continued)U

Did the patient have any of the following preexisting characteristics that may have contributed to the event? (check all that apply)
 Allergies (describe below)		 Pregnancy
 Alcohol/drug use		 Premature infant
 COPD		 Smoking
 Coronary heart disease		 Status post total hysterectomy or salpingioherectomy
 Diabetes		 Relevant accidents (i.e. hit head) (describe below)
 Hepatic/renal dysfunction		 Stroke
 Hypertension		 Surgery
 Immuno-compromised		 No preexisting characteristics
 Morbidly obese		 Not known
 Pneumonia		 Not applicable
 Other: (describe below)
	Please use this space to describe the relevant accident preceding the event, the relevant patient allergies, (i.e. latex allergy, a particular medication allergy, an allergy to a particular material or biomaterial, etc.) and/or other preexisting characteristics.
	Please describe the relevant accident preceding the event
	Other characteristics or medical conditions.

USection 3: Patient Information (continued)U

	Please provide any other information about the patient that may have influenced the outcome of the event:

Section 4: Device Information

PLEASE USE A SEPARATE PAGE FOR EACH DEVICE INVOLVED

Device manufacturer’s name:

Street address:

City:

State:

Zip Code:

When do you plan to return the device to the manufacturer? date: (mm/dd/yyyy) [Optional]

Device brand name:

Type of device:

Approximate age of device:

If the device is a disposable device, was the packaging saved?

 Yes

 Not known

 No

 Not applicable

Is this a single use device that was reprocessed and reused on a patient?

 Yes

 Unknown

 No

If “Yes,” please fill in all that are available:

Name of Reprocessor:

Reprocessor’s Street Address:

City:

State:

Zip:

Is this a laboratory device or laboratory test?

 Yes

 No

If “Yes,” please answer the following questions:

Did the problem involve: (check all that apply)

 The reagent

 The instrument

 Single use or rapid test

 Other: (specify)

Section 4: Device Information (continued) Section 4: Device Information (continued)

Is this a recurrent problem with this assay, test kit, or instrument?

 Yes

 No

If “Yes,” please provide additional details:

Which of the following problems did you observe? (check all that apply)

 Calibration

 Repeated error message

 Reproducibility

 Analytical sensitivity

 Analytical specificity

 Quality control

 Questionable patient results

 Reagent(s)

 Inadequate or unclear

 Poor test / instrument design

instructions for use

 Specimen problems

 Performance described in

 Other: (specify)

package insert not met

 Patient related problems

Please describe any follow-up actions below: (check all that apply)

 Repeated assay, results OK

 Repeated assay, still problems

reported out

 Replaced reagents

 Opened new lot

 Manufacturer notified

 Called for service, received adequate

 Product not available to

response from manufacturer

return to manufacturer

 Discontinued all use of product

 Not known

 Not applicable

 Other: (specify)

 No

Device numbers: (please fill in all that are available)

Device serial #:

Device model #:

Device lot #:

Device catalog #:

Other device #:

Expiration date: (mm/dd/yyyy)

Has the facility discontinued use of the device due to the event? [Optional]

 Yes

 Not known

 No

 Not applicable

Section 4: Device Information

Section 4: Device Information (continued) If the device was implanted, give the implant date: (mm/dd/yyyy)

If the device was explanted, give the explant date: (mm/dd/yyyy)

Was the device returned to the manufacturer?
 Yes			 Not known
 No			 Not applicable
	If you checked “Yes,” when was returned? (mm/dd/yyyy)
	How was the device returned to the manufacturer?
	 Returned to the manufacturer by mail
	 Given to manufacturer field representative
	 Other method (please specify):
	If you checked “No,” where is the device now?
	 Retained by the patient or patient representative
	 Discarded
	 Retained by the hospital
	 Other (please specify):
Is the device available at your facility for evaluation?
 Yes			 Not known
 No			 Not applicable
Have you made the manufacturer aware of this problem/issue?
 Yes		 No known
 No
	If you checked “Yes,” what has been the manufacturer’s response?
	Section 4: Device Information (continued)
	Can this information be made available to the public?
	 Yes	 No

Do you intend to return the device to the manufacturer in the near future?
 Yes		 No
	When do you plan to return the device to the manufacturer? date: (mm/dd/yyyy)

Section 5: Test Information

Please enter all relevant tests/laboratory data: (enter each test separately)
Test Type/ Test Performed	Date (mm/dd/yyyy)	Results

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