FDA Adverse Event
Malfunction
Summary report: N
PRIME BIG WHEEL STRETCHER,30"
MDR report key: 2113443
·
Received May 25, 2011
Report
- Report Number
- 1831750-2011-05075
- Event Type
- Malfunction
- Date Received
- May 25, 2011
- Date of Event
- April 27, 2011
- Report Date
- April 27, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION RESULT: BRAKE LINK ASSEMBLY.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE BRAKES ARE VERY HARD TO ENGAGE AND THE PATIENT FOOT LEFT CASTER IS NOT ENGAGING. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRIME BIG WHEEL STRETCHER,30" | HOSPITAL WHEELED STRETCHER | FPO | STRYKER MEDICAL | 1115000030 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |