FDA Adverse Event
Malfunction
Summary report: N
MX-PRO AMBULANCE COT
MDR report key: 2092407
·
Received May 3, 2011
Report
- Report Number
- 1831750-2011-04218
- Event Type
- Malfunction
- Date Received
- May 3, 2011
- Date of Event
- April 5, 2011
- Report Date
- April 5, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
END PLATE ASSEMBLY: CONFIRMED SHARP EDGES.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE END PLATE AT THE BOTTOM OF THE FOWLER CYLINDER WAS BROKEN AND THE FOWLER COULD NOT BE SAFELY USED. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MX-PRO AMBULANCE COT | STRETCHER, WHEELED | FPO | STRYKER MEDICAL | 6080 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |