FDA Adverse Event
Injury
Summary report: N
9614385-2007-00015
MDR report key: 840556
·
Received April 12, 2007
Report
- Report Number
- 9614385-2007-00015
- Event Type
- Injury
- Date Received
- April 12, 2007
- Product Code
- FWM
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
DEFLATION OF THE LEFT BREAST IMPLANT. BILATERAL EXCHANGE WITH MENTOR 525 DEVICES. VISUAL INSPECTION IDENTIFIED A SMALL TEAR WHICH IS LOCATED UNDER THE LEFT RAW SILICONE ANCHORAGE POINT (WHEN THE PRODUCT WAS HELD IN SUCH A POSITION THAT THE BRAND NAME WAS UPRIGHT AND HORIZONTAL), WHICH MEASURES APPROX 3MM IN LENGTH. PRESSURE TESTING IDENTIFIED NO OTHER LEAKS OR BREACHES. MICROSCOPIC EXAMINATION (X10) OF THE TEAR IDENTIFIED RAGGED EDGES WHICH ARE INDICATIVE OF AN EXCESSIVE FORCE HAVING BEING USED. THE PRODUCT MET ALL MFG AND QUALITY SPECS POST MFR. THE TEAR IS NOT A MFG FAULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FWM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |