FDA Adverse Event
Malfunction
Summary report: N
BREAST IMPLANT
MDR report key: 3035504
·
Received April 6, 2006
Report
- Report Number
- 3035504
- Event Type
- Malfunction
- Date Received
- April 6, 2006
- Date of Event
- March 22, 2006
- Report Date
- March 30, 2006
- Manufacturer
- MENTOR
- Product Code
- FWM
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
BREAST IMPLANT DEFLATED. (B)(6) 2006 10:57 AM (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BREAST IMPLANT | FWM | MENTOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |