FDA Adverse Event
Malfunction
Summary report: N
BATT-HANDPIECE MOD F/TRS
MDR report key: 2882294
·
Received December 20, 2012
Report
- Report Number
- 8030965-2012-01623
- Event Type
- Malfunction
- Date Received
- December 20, 2012
- Report Date
- November 21, 2012
- Manufacturer
- SYNTHES GMBH
- Product Code
- HWE
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.
Description of Event or Problem · 1
DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE BOTTOM BUTTON OF THE BATTERY HANDPIECE IS STICKING/JAMMING REPEATEDLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BATT-HANDPIECE MOD F/TRS | BATTERY HANDPIECE | HWE | SYNTHES GMBH | SER.-NR. 5633 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |