FDA Adverse Event
Injury
Summary report: N
9614385-2007-00011
MDR report key: 835400
·
Received April 2, 2007
Report
- Report Number
- 9614385-2007-00011
- Event Type
- Injury
- Date Received
- April 2, 2007
- Product Code
- FWM
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
VISUAL INSPECTION IDENTIFIED A 2MM TEAR ON THE VALVE/SHELL INTERFACE AT THE SIX O'CLOCK POSITION (WHEN THE PRODUCT WAS HELD IN SUCH A POSITION THAT THE BRAND NAME WAS UPRIGHT AND HORIZONTAL). PRODUCT SHELL SHOWS EVIDENCE OF FOLDING/CREASING IN SITU ALTHOUGH NONE OF THE FOLDS HAVE DEVELOPED INTO SPLITS. PRESSURE TESTING CONFIRMED THE VALVE/SHELL TEAR AND SHOWED THE REMAINDER OF THE DEVICE TO BE FREE FROM ANY ADD'L BREACHES. MICROSCOPIC EXAMINATION (X10) OF THE TEAR 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 |