FDA Adverse Event
Malfunction
Summary report: N
TREATMENT RECLINER
MDR report key: 2861150
·
Received November 2, 2012
Report
- Report Number
- 1831750-2012-11459
- Event Type
- Malfunction
- Date Received
- November 2, 2012
- Date of Event
- September 6, 2012
- Report Date
- September 6, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FRJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
RESULTS: RECLINER MECHANISM.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE FOOT SECTION WILL NOT LOCK IN PLACE PROPERLY. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TREATMENT RECLINER | RECLINER | FRJ | STRYKER MEDICAL | 3500000710 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |