FDA Adverse Event
Malfunction
Summary report: N
SM104 M-SERIES W/5TH WHEEL
MDR report key: 2140676
·
Received June 15, 2011
Report
- Report Number
- 1831750-2011-05994
- Event Type
- Malfunction
- Date Received
- June 15, 2011
- Date of Event
- May 18, 2011
- Report Date
- May 18, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE PATIENT'S RIGHT SIDE RAIL WOULD NOT LATCH AND THE TOP RAIL IS CRACKED PRESENTING SHARP EDGES. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SM104 M-SERIES W/5TH WHEEL | HOSPITAL WHEELED STRETCHER | FPO | STRYKER MEDICAL | 1007 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |