FDA Adverse Event
Malfunction
Summary report: N
SM204 M-SERIES W/BIG WHEEL
MDR report key: 2140835
·
Received May 31, 2011
Report
- Report Number
- 1831750-2011-05301
- Event Type
- Malfunction
- Date Received
- May 31, 2011
- Date of Event
- May 3, 2011
- Report Date
- May 3, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
RESULTS: FOWLER ASSEMBLY.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE FOWLER ASSEMBLY HAD A BROKEN WELD EXPOSING SHARP EDGES AND IT WOULD NOT HOLD WEIGHT. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SM204 M-SERIES W/BIG WHEEL | HOSPITAL WHEELED STRETCHER | FPO | STRYKER MEDICAL | 1015 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |