FDA Adverse Event
Summary report: N
EP IMPLANT TRAY
MDR report key: 2010341
·
Received February 17, 2011
Report
- Report Number
- 2010341
- Date Received
- February 17, 2011
- Date of Event
- September 8, 2010
- Report Date
- February 17, 2011
- Manufacturer
- AVID MEDICAL INC
- Product Code
- LRP
- Report Source
- User Facility report
- Reporter Location
- FL, US
Narratives
Description of Event or Problem · 1
IMPLANT PACK OPENED AND BLACK SPECKS WERE FOUND ON THE X-RAY DETECTABLE SPONGES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EP IMPLANT TRAY | TRAY, SURGICAL | LRP | AVID MEDICAL INC | * | 712255 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR |