FDA Adverse Event
Malfunction
Summary report: N
TOTAL JOINT PACK
MDR report key: 1941408
·
Received December 14, 2010
Report
- Report Number
- 1941408
- Event Type
- Malfunction
- Date Received
- December 14, 2010
- Date of Event
- December 8, 2010
- Report Date
- December 14, 2010
- Manufacturer
- AVID MEDICAL, INC.
- Product Code
- KDD
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
LONG BLACK HAIR WAS FOUND IN THE CUSTOM STERILE KIT DURING SET UP. THERE WAS NO PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTAL JOINT PACK | KIT, SURGICAL INSTRUMENT, DISPOSABLE | KDD | AVID MEDICAL, INC. | HFHM-008-09 | 726704 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |