Allegation Reporting Respondent

Allegation Report
Allegation Report
Tracking Information
Have you previously submitted this allegation to the FDA?

( ) Yes
( ) No

If known, please enter the FDA assigned allegation number (CPT or COM number):
Please indicate why you are contacting the FDA regarding the previous allegation:
( ) To provide additional information regarding the allegation (e.g. corrective action plan, etc.).
( ) To check on the status of the allegation.
( ) Other
>

If Other, please indicate why you are contacting the FDA regarding the previous allegation:

Please identify the subject matter or type of complaint you are reporting to the FDA:
>

If Other, please specify further:

Please select your relationship to the product and/or manufacturer of the product
reported in this allegation:
>

•

If Other, please specify relationship:

Allegation Narrative Information
Please describe in as much detail as possible the event(s), injuries and/or illnesses bringing about this allegation
(Max 4000 Characters):

•

Please provide any additional information you feel will assist the FDA in addressing this allegation. Attach documents by
clicking on the add (+) button below and locating the necessary files on your computer:
No Files Attached.
Please select the most appropriate patient problem codes associated with your allegation by clicking on the add (+)
button below and searching for the patient code or name filter criteria: [QUESTION TYPE NOT YET IMPLEMENTED:
MDR CODE LIST]
Please select the most appropriate device problem codes associated with your allegation by clicking on the add (+)
button below and searching for the device code or name filter criteria: [QUESTION TYPE NOT YET IMPLEMENTED:
MDR CODE LIST]

Reporter Information
Please indicate whether
you would like your
personal identification
information to remain
confidential. Note: All

•

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Allegation Report
personal identifiers will be
protected in accordance
with the Freedom of
Information Act (FOIA),
Privacy Act and 21 Code of
Federal Regulations (CRF)
Parts 20 and 21
Please enter your contact information below.
Contact Name
Email Address
Address
Telephone Number
If CDRH needs to contact you (e.g., follow up questions, etc), please indicate your preferred
method of communication:
>

If Other, please specify the preferred method of communication:

Manufacturer Information
Please enter the Manufacturer information below as much as possible.
Contact Name
Email Address
Manufacturer Name
Address
Telephone Number
Fax Number
FEI
Other Manufacturer Information (e.g., website, etc):

Importer Information
Please enter the Importer information below as much as possible.
Contact Name
Email Address
Importer Name
Address
Telephone Number

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Allegation Report
Fax Number
FEI
Other Importer Information (e.g., website, etc):

Product Information
Is your allegation referencing an individual product (single unit) or all products of this type?

( ) All Types
( ) Single Unit
( ) Unknown

Please enter the brand and/or proprietary name of the product:

Please select the product common name by clicking on the add (+) button below and searching for the product code:
No product code selected.
Enter the Unique Device Identifier (UDI), if known:
Please indicate all of the product identifiers you will be submitting:

[
[
[
[
[

]
]
]
]
]

Device Model Number
Catalog Number
Serial Number
Lot Number
Other Identification Number

Please indicate your method of providing the model number(s):
Model Number(s):
No Information Provided.
Please attach supporting documentation:
No File Attached.
Please indicate your method of providing the catalog number(s):
Catalog Number(s):
No Information Provided.
Please attach supporting documentation:
No File Attached.
Please indicate your method of providing the serial number(s):
Serial Number(s):
No Information Provided.
Please attach supporting documentation:
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Allegation Report
No File Attached.
Please indicate your method of providing the lot number(s):
Lot Number(s):
No Information Provided.
Please attach supporting documentation:
No File Attached.
Please indicate your method of providing the other product identifier(s):
Other Product Identifier(s):
No Information Provided.
Please attach supporting documentation:
No File Attached.
Please select the appropriate marketing status of the product:

( ) 510(k) Premarket
Notification
( ) Premarket Approval (PMA)
( ) Exempt
( ) Preamendment
( ) Unknown
( ) Other

Please provide the number, if known.
No Information Provided.
Please enter the age of the product:
>

Please specify the units for the age of the product:

( ) Day(s)
( ) Month(s)
( ) Year(s)

Please enter the expiration date of the product, if known (MM/DD/YYYY):
Please describe the intended use of the product:

Purchasing Information
What was the product status at the date of purchasing or acquiring the product?
>

If Other, please specify the product status at the date of
purchasing or acquiring the product:

Please enter the location where the product was purchased below.
Purchasing Location
Name (e.g.
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Allegation Report
Pharmacy,
Department Store,
etc.)
Address
Telephone Number
Fax Number
Other Purchasing Location Information (e.g., website, etc):

Medical Device Reporting
Have you submitted related information in the form of a Medical Device Report (MDR) to the
FDA?

( ) Yes
( ) No

Please enter MDR number(s) by clicking the add (+) button below, if known:
No Information Provided.
If applicable, please provide copies of MDR(s) previously submitted to the FDA (e.g., MedWatch Report 3500 or 3500A,
complaint records, etc.):
No Files Attached.

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