FDA Adverse Event
Malfunction
Summary report: N
PRIME 5TH WHEEL STRETCHER, 26"
MDR report key: 3396485
·
Received October 9, 2013
Report
- Report Number
- 0001831750-2013-09514
- Event Type
- Malfunction
- Date Received
- October 9, 2013
- Date of Event
- September 13, 2013
- Report Date
- September 13, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE MATTRESS COULD NOT ADHERE TO THE LITTER SURFACE DUE TO MISSING VELCRO. 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 |
|---|---|---|---|---|---|---|---|
| 514435 | PRIME 5TH WHEEL STRETCHER, 26" | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |