FDA Adverse Event
Injury
Summary report: N
9614385-2006-00081
MDR report key: 793217
·
Received December 4, 2006
Report
- Report Number
- 9614385-2006-00081
- Event Type
- Injury
- Date Received
- December 4, 2006
- Product Code
- FWM
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
DEFLATION OF LEFT BREAST IMPLANT. BILATERAL EXCHANGE WITH MENTOR HIGH PROFILE SALINE DEVICES. VISUAL INSPECTION IDENTIFIED A VALVE SHELL TEAR APPROXIMATELY 4MM IN LENGTH, WHICH IS LOCATED ON THE 6 0'CLOCK POSITION_(WHEN THE PRODUCT WAS HELD IN SUCH A POSTION THAT THE BRAND NAME WAS UPRIGHT AND HORIZONTAL). PRESSURE TESTING COULD NOT BE COMPLETED DUE TO THE POSITION OF THE TEAR. MICROSCOPIC EXAMINATION (X10) OF THE TEAR IDENTIFIED RAGGED EDGES WHICH ARE INDICATIVE OF AN EXCESSIVE FORCE HAVING BEEN USED ON THE PRODUCT. THE PRODUCT MET ALL MANUFACTURING AND QUALITY SPECIFICATIONS POST MFR. CONCLUSION: THE TEAR IS NOT A MANUFACTURING FAULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FWM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |