FDA Adverse Event
Malfunction
Summary report: N
INNOMED, INC.
MDR report key: 1772185
·
Received July 21, 2010
Report
- Report Number
- MW5016826
- Event Type
- Malfunction
- Date Received
- July 21, 2010
- Report Date
- July 21, 2010
- Manufacturer
- INNOMED, INC.
- Product Code
- HWK
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- GA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
TREPHINE DRILL BIT BROKE DURING PROCEDURE. ALL PIECES RECOVERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INNOMED, INC. | 4.7 MM TREPHINE | HWK | INNOMED, INC. | 06095 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |