FDA Adverse Event
Injury
Summary report: N
JOURNEY I BCS/RENASY
MDR report key: 2991650
·
Received March 6, 2013
Report
- Report Number
- 1020279-2013-00148
- Event Type
- Injury
- Date Received
- March 6, 2013
- Date of Event
- April 1, 2011
- Report Date
- March 4, 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
REVISION - PAIN PERSISTENT IMPINGEMENT, TENDINITIS AND PAIN OF LEFT KNEE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 95146 | JOURNEY I BCS/RENASY | JOURNEY FEM OX NP BCS LT SZ 6 | JWH | SMITH & NEPHEW, INC. | 08HM09524 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Required Intervention |