FDA Adverse Event
Injury
Summary report: N
9614385-2007-00012
MDR report key: 835411
·
Received April 2, 2007
Report
- Report Number
- 9614385-2007-00012
- Event Type
- Injury
- Date Received
- April 2, 2007
- Product Code
- FWM
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
DEFLATION OF THE RIGHT BREAST IMPLANT. BILATERAL EXCHANGE WITH UNK DEVICES. VISUAL INSPECTION IDENTIFIED A 5MM BREACH ON THE VALVE/SHELL INTERFACE AT THE TWELVE O'CLOCK POSITION. (WHEN THE PRODUCT WAS HELD IN SUCH A POSITION THAT THE BRAND NAME WAS UPRIGHT AND HORIZONTAL). PRESSURE TESTING CONFIRMED THE PRESENCE OF THE BREACH AND SHOWED THE REMAINDER OF THE DEVICE TO BE FREE OF ANY ADD'L BREACHES. MICROSCOPIC EXAMINATION (X10) OF THE BREACH IDENTIFIED RAGGED EDGES WHICH ARE INDICATIVE OF EXCESSIVE FORCE HAVING BEEN USED. THE PRODUCT MET ALL MFG AND QUALITY SPECS POST MFR. VALVE/SHELL BREACH NOT CHARACTERISTIC OF A MFG FAULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FWM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |