FDA Adverse Event
Malfunction
Summary report: N
M-1 COT - BASE HIGH LOAD 28
MDR report key: 2022511
·
Received February 15, 2011
Report
- Report Number
- 1831750-2011-01395
- Event Type
- Malfunction
- Date Received
- February 15, 2011
- Date of Event
- January 15, 2011
- Report Date
- January 17, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SI
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
STRYKER DISTRIBUTOR IN SLOVENIA REPORTED, THERE WAS A BROKEN PIN. THE AMBULANCE WAS NOT INVOLVED IN TRAFFIC ACCIDENT. IT WAS FURTHER REPORTED, THE BROKEN PIN CAUSED DAMAGE ON THE AMBULANCE'S REAR DOOR. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES HAVE BEEN REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | M-1 COT - BASE HIGH LOAD 28 | STRETCHER, WHEELED | FPO | STRYKER MEDICAL | 6100 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |