FDA Adverse Event
Malfunction
Summary report: N
TREATMENT RECLINER
MDR report key: 2000229
·
Received February 3, 2011
Report
- Report Number
- 1831750-2011-01030
- Event Type
- Malfunction
- Date Received
- February 3, 2011
- Date of Event
- January 7, 2011
- Report Date
- January 7, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FRK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SVC REPORT THAT THE CASTER WHEEL IS BENT. BOTH THE FRONT CASTER WHEELS WHERE THEY ATTACH TO THE WOOD FRAME ARE NO LONGER ATTACHED. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TREATMENT RECLINER | EXAMINATION AND TREATMENT CHAIR | FRK | STRYKER MEDICAL | 3500000710 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |