FDA Adverse Event
Malfunction
Summary report: N
PRIME 5TH WHEEL STRETCHER 30IN
MDR report key: 11280780
·
Received February 4, 2021
Report
- Report Number
- 0001831750-2021-00496
- Event Type
- Malfunction
- Date Received
- February 4, 2021
- Date of Event
- January 19, 2021
- Report Date
- February 4, 2021
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- UDI-DI
- 07613327278156
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT BRAKES CANNOT BE ENGAGED. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 180114 | PRIME 5TH WHEEL STRETCHER 30IN | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO | 1105 | 07613327278156 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |