FDA Adverse Event
Malfunction
Summary report: N
M-1 COT - BASE HIGH LOAD 28
MDR report key: 2022115
·
Received March 10, 2011
Report
- Report Number
- 1831750-2011-02331
- Event Type
- Malfunction
- Date Received
- March 10, 2011
- Date of Event
- February 11, 2011
- Report Date
- February 11, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
OTHER - SLIDE TUBE WELDMENT.
Description of Event or Problem · 1
COT WILL NO LONGER FIT INTO THE COT LOCK SYSTEM; THIS IS DUE TO THE FACT THAT THE FOOT END SLIDE TUBE WELDMENT IS BENT. COT WAS BEING USED AT THE TIME. THERE WAS PT INVOLVEMENT, HOWEVER, NO 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 |