FDA Adverse Event
Malfunction
Summary report: N
MENTOR BREAST IMPLANT
MDR report key: 2831948
·
Received November 7, 2012
Report
- Report Number
- MW5027584
- Event Type
- Malfunction
- Date Received
- November 7, 2012
- Date of Event
- October 30, 2012
- Report Date
- November 7, 2012
- Manufacturer
- MENTOR
- Product Code
- FWM
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
DEFLATION OF SALINE BREAST IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MENTOR BREAST IMPLANT | SALINE BREAST IMPLANT | FWM | MENTOR | 5545412 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |