FDA Adverse Event
Malfunction
Summary report: N
UNK
MDR report key: 2043151
·
Received March 15, 2011
Report
- Report Number
- 1831750-2011-02498
- Event Type
- Malfunction
- Date Received
- March 15, 2011
- Date of Event
- February 17, 2011
- Report Date
- February 17, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION UNDERWAY.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE COT IS NOT LOCKING IN THE FASTENING SYSTEM. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK | UNK | FPO | STRYKER MEDICAL | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |