FDA Adverse Event
Malfunction
Summary report: N
SM104 MSERIES W5TH WHL
MDR report key: 2110308
·
Received May 20, 2011
Report
- Report Number
- 1831750-2011-04927
- Event Type
- Malfunction
- Date Received
- May 20, 2011
- Date of Event
- April 22, 2011
- Report Date
- April 22, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE PT RIGHT RAIL IS NOT LOCKING AND THE TOP RAIL IS BROKEN PRESENTING SHARP EDGES. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SM104 MSERIES W5TH WHL | HOSPITAL WHEELED STRETCHER | FPO | STRYKER MEDICAL | 1005 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |