FDA Adverse Event
Other
Summary report: N
NONE
MDR report key: 1711507
·
Received May 28, 2010
Report
- Report Number
- MW5016181
- Event Type
- Other
- Date Received
- May 28, 2010
- Report Date
- May 28, 2010
- Product Code
- FWM
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IN COMPLIANCE WITH MDR REPORTING REGULATION, SECTION 803.22, WE WISH TO INFORM YOU OF AN ADVERSE EVENT REPORT ASSOCIATED WITH ANOTHER MANUFACTURER'S DEVICE WHICH HAS BEEN RECEIVED AT ALLERGAN INC. (B) (4). THE FOLLOWING INFO WAS PROVIDED: (B) (6). EXPLANT PHYSICIAN: DR. (B) (6). ALLEGED EVENT: HEALTH PROFESSIONAL REPORTS A LEFT SIDE DEFLATION OF A NON-ALLERGAN DEVICE. IMPLANT DATE: (B) (6) 1997. (B) (6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NONE | FWM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |