FDA Adverse Event
Injury
Summary report: N
INTERTAN
MDR report key: 2211335
·
Received August 15, 2011
Report
- Report Number
- 1020279-2011-00325
- Event Type
- Injury
- Date Received
- August 15, 2011
- Report Date
- August 15, 2011
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JDS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE NAIL FRACTURED AFTER IMPLANTATION REQUIRING A REVISION SURGERY TO CORRECT. IT WAS STATED THAT THE HOSPITAL DISPOSED OF THE EXPLANTED DEVICES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERTAN | NAIL | JDS | SMITH & NEPHEW, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |