FDA Adverse Event
Injury
Summary report: N
TC PLUS
MDR report key: 2924659
·
Received January 22, 2013
Report
- Report Number
- 9613369-2013-00003
- Event Type
- Injury
- Date Received
- January 22, 2013
- Date of Event
- January 7, 2013
- Report Date
- January 18, 2013
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REMOVAL SURGERY OF TC-PLUS WAS PERFORMED. THE CAUSE IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29590 | TC PLUS | TC PLUS | JWH | SMITH & NEPHEW, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |