Form 806 Reports of Corrections and Removals of Medical Devices a

CDRH Voluntary Compliance: Corrections and Removals Report
Tracking Information
Tracking Information
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Please indicate which of the following actions you are reporting in this submission:
( ) A new correction or removal report
( ) An expansion of an existing correction or removal
( ) Additional information for an existing correction or removal
Please enter the Correction or Removal Report Details or the previous correction or removal number if this is
an expansion to or additional information for an existing report:
Please enter the registration number of the entity responsible for the submission of the report:

•

>

Please enter the Correction or Removal Report Date:

•

>

Please enter the Correction or Removal Sequence Number:

•

>

Please enter the Correction or Removal Report Type:

• ( ) C
( ) R
•

Please identify the District Office to which this correction or removal applies:
Note: Select the FDA District Office in which the recalling firm is located. If you are a foreign manufacturer, select the
FDA District Office in which the importer or US agent is located.

Contact Information
Submitter Information
Responsible Representative
Please enter the following information about the Submitter below or select the information from the Address Book.

•

Contact Name
Occupation Title
Email Address
Establishment Name
Division Name
Address
Telephone Number
Fax Number
FEI
Other Submitter Information (e.g., website, etc):

Created By: eSubmitter on 3/5/2014 at 3:38 PM

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CDRH Voluntary Compliance: Corrections and Removals Report
Manufacturer Information
Responsible Representative
Please enter the following information about the Manufacturer below or select the information from the Address
Book.

•

Contact Name
Occupation Title
Email Address
Establishment Name
Division Name
Address
Telephone Number
Fax Number
FEI
Other Manufacturer Information (e.g., website, etc):

Recalling Firm Information
Responsible Representative
Please enter the following information about the Recalling Firm below or select the information from the Address
Book.

•

Contact Name
Occupation Title
Email Address
Establishment Name
Division Name
Address
Telephone Number
Fax Number
FEI
Other Recalling Firm Information (e.g., website, etc):

Importer Information
Created By: eSubmitter on 3/5/2014 at 3:38 PM

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CDRH Voluntary Compliance: Corrections and Removals Report
Is there an importer?

( ) Yes
( ) No

Responsible Representative
Please enter the following information about the Importer below or select the information from the Address Book.
Contact Name
Occupation Title
Email Address
Establishment Name
Division Name
Address
Telephone Number
Fax Number
FEI
Other Importer Information (e.g., website, etc):

Corrections and Removals Report
Event Details
Please select the regulatory violation being reported in this correction or removal:

Please describe the event(s) giving rise to the information reported:

•

Please describe any corrective or removal actions that have been, and are expected to be taken:

•

Please describe any illness or injuries that have occurred with the use of the device(s):

•

Please select the most appropriate device problem code(s) associated with the correction or removal 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]
Please select the most appropriate patient problem code(s) associated with the correction or removal 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]
Have you submitted MDR(s) to the FDA for any illnesses or injuries that have occurred with use of the
device(s)?
Created By: eSubmitter on 3/5/2014 at 3:38 PM

( ) Yes
( ) No
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CDRH Voluntary Compliance: Corrections and Removals Report
Please provide copies of MDR(s) previously submitted to the FDA (e.g. MedWatch Report 3500 or 3500A, complaint
records, etc.):
No Files Attached.
Note:

Please provide the MDR number(s) of the MDR(s) previously submitted to the FDA on next screen.

Communication Documentation
Attach a copy of all communications regarding the correction or removal by clicking on the add (+) button below and
locating the necessary file(s):

•

No Files Attached.

Additional Documentation
Additional Information
Please attach a complete set of product labeling (including all private labels) by clicking on the add (+) button below and
locating the necessary file(s):
No Files Attached.
Please attach any Root Cause Analyses by clicking on the add (+) button below and locating the necessary file(s):
No Files Attached.
Please attach any Corrective or Preventative Actions by clicking on the add (+) button below and locating the necessary
file(s):
No Files Attached.
Please attach any Health Hazard Assessments by clicking on the add (+) button below and locating the necessary
file(s):
No Files Attached.
Please attach the Recall Strategy by clicking on the add (+) button below and locating the necessary files:
No Files Attached.
Please attach any additional relevant documents by clicking on the add (+) button below and locating the necessary
file(s):
No Files Attached.

Product Information
Device Brand Name: 1
Please enter the device brand name:

•

Please select the device common name by clicking on the add (+) button below and searching for the product code
or name filter criteria:

Created By: eSubmitter on 3/5/2014 at 3:38 PM

•

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CDRH Voluntary Compliance: Corrections and Removals Report
No product code selected.
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Please enter the device intended use:

Please enter the Unique Device Identifier (UDI), if known:
• ( ) 510(k) Premarket
Notification
( ) Premarket Approval (PMA)
( ) Exempt
( ) Preamendment
( ) Other

Please select the appropriate marketing status of the device:

Please enter the number:
No Information Provided.
Please indicate all of the device identifiers you will be submitting:

• [
[
[
[
[

]
]
]
]
]

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

Please indicate your method of providing the device model number(s):
Device 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:
No File Attached.
Please indicate your method of providing the lot number(s):
Lot Number(s):
Created By: eSubmitter on 3/5/2014 at 3:38 PM

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CDRH Voluntary Compliance: Corrections and Removals Report
No Information Provided.
Please attach supporting documentation:
No File Attached.
Please indicate your method of providing the other device identifier(s):
Other Device Identifier(s):
No Information Provided.
Please attach supporting documentation:
No File Attached.

Correction or Removal Product Details
Please enter the total number of devices manufactured subject to the correction or
removal:
>

Please enter the date range of manufacture:

Please enter the total number of devices distributed subject to the correction or removal:
>

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•

Please enter the date range of distribution:

Please enter the total number in the same batch, lot or equivalent unit of production:
Please select the device expiration or expected end of life date format:

•
•

Please enter the device expiration date or expected end of life date:
Please describe the device expiration date or expected end of
life date:

Consignee(s) Information

Created By: eSubmitter on 3/5/2014 at 3:38 PM

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