FDA Adverse Event
Malfunction
Summary report: N
SM204 M-SERIES W/BIG WHEEL
MDR report key: 1933278
·
Received December 2, 2010
Report
- Report Number
- 1831750-2010-04359
- Event Type
- Malfunction
- Date Received
- December 2, 2010
- Date of Event
- November 5, 2010
- Report Date
- November 5, 2010
- Manufacturer
- STRYKER CORP., MEDICAL DIVISION
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY THE DISTRIBUTOR THAT THE SIDE RAILS DO NOT CLOSE PROPERLY. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SM204 M-SERIES W/BIG WHEEL | HOSPITAL WHEELED STRETCHER | FPO | STRYKER CORP., MEDICAL DIVISION | 1015 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |