FDA Adverse Event
Summary report: N
FORMULA AGGRESSIVE PLUS 4.0
MDR report key: 4252770
·
Received November 7, 2014
Report
- Report Number
- 4252770
- Date Received
- November 7, 2014
- Date of Event
- November 1, 2014
- Report Date
- November 7, 2014
- Manufacturer
- HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS
- Product Code
- NBH
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- RI, US
Narratives
Description of Event or Problem · 1
ARTHROSCOPIC SHAVER BLADE MALFUNCTIONED DURING SURGICAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 719342 | FORMULA AGGRESSIVE PLUS 4.0 | ACCESSORIES, ARTHROSCOPIC | NBH | HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS | 0375-544-00 | 14239CE2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |