FDA Adverse Event
Injury
Summary report: N
9614385-2006-00073
MDR report key: 790616
·
Received November 21, 2006
Report
- Report Number
- 9614385-2006-00073
- Event Type
- Injury
- Date Received
- November 21, 2006
- Product Code
- FWM
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
DEFLATION OF BILATERAL BREAST IMPLANTS. BILATERAL EXCHANGE WITH MCGHAN DEVICES. VISUAL INSPECTION IDENTIFIED A VALVE - SHELL TEAR APPROXIMATELY 3MM IN LENGTH, WHICH IS LOCATED AT THE 11 O'CLOCK POSITION (WHEN THE PRODUCT WAS HELD IN SUCH A POSITION THAT THE BRAND NAME WAS UPRIGHT AND HORIZONTAL). PRESSURE TESTING COULD NOT BE COMPLETED DUE TO THE POSITION ON THE TEAR. MICROSCOPIC EXAMINATION (X10) OF THE TEAR IDENTIFIED RAGGED EDGES WHICH ARE INDICATIVE OF AN EXCESSIVE FORCE HAVING BEING USED ON THE PRODUCT. THE PRODUCT MET ALL MANUFACTURING AND QUALITY SPECIFICATIONS POST MFR. 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 |