FDA Adverse Event
Malfunction
Summary report: N
TRAUMA SERIES
MDR report key: 2112245
·
Received April 29, 2011
Report
- Report Number
- 1831750-2011-04153
- Event Type
- Malfunction
- Date Received
- April 29, 2011
- Date of Event
- April 1, 2011
- Report Date
- April 1, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE HEAD SECTION WELD WAS BROKEN AND THE FOWLER WAS NOT STABLE. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT.
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 | UNK |