FDA Adverse Event
Malfunction
Summary report: N
TRAUMA SERIES
MDR report key: 2112276
·
Received April 29, 2011
Report
- Report Number
- 1831750-2011-04142
- Event Type
- Malfunction
- Date Received
- April 29, 2011
- Date of Event
- March 11, 2011
- Report Date
- April 1, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT UPON INSPECTION IT WAS OBSERVED THAT THE WELD HAS BROKEN AT THE BOTTOM OF THE HAND RAIL AND THE SIDE RAIL CANNOT BE LATCHED UP. NO ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRAUMA SERIES | HOSPITAL WHEELED STRETCHER | FPO | STRYKER MEDICAL | 1002 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |