FDA Adverse Event
Injury
Summary report: N
MENTOR
MDR report key: 1080845
·
Received July 22, 2008
Report
- Report Number
- MW5007748
- Event Type
- Injury
- Date Received
- July 22, 2008
- Report Date
- July 22, 2008
- Manufacturer
- MENTOR
- Product Code
- FWM
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
AT 6 WEEK POST-OP BREAST AUG. IN OCEAN, WAVE HIT CHEST AND WOUND DEHISCED CHANGED IMPLANT AND WOUND CLOSURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MENTOR | BREAST IMPLANT | FWM | MENTOR | 5812592 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Other |