FDA Adverse Event
Injury
Summary report: N
NAIL CAPS
MDR report key: 1982731
·
Received February 9, 2011
Report
- Report Number
- 1020279-2011-00028
- Event Type
- Injury
- Date Received
- February 9, 2011
- Report Date
- February 9, 2011
- Manufacturer
- SMITH & NEPHEW, INC
- Product Code
- JDS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PACKAGE CONTAINED THE INCORRECT NAIL CAP CAUSING AN EXTENSION OF SURGERY TIME BY MORE THAN 40 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NAIL CAPS | NAIL CAP {} 5MM | JDS | SMITH & NEPHEW, INC | 10AM00138 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |