FDA Adverse Event
Malfunction
Summary report: N
SECURE 3 MED/SURG BED
MDR report key: 2112534
·
Received May 25, 2011
Report
- Report Number
- 1831750-2011-05038
- Event Type
- Malfunction
- Date Received
- May 25, 2011
- Date of Event
- May 3, 2011
- Report Date
- May 3, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE FOOTBOARD WAS BROKEN INTO TWO PIECES AND THERE WERE SHARP EDGES AND AREAS WHERE FLUID COULD INGRESS. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SECURE 3 MED/SURG BED | A/C POWERED HOSPITAL BED | FNL | STRYKER MEDICAL | 3002S3EX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |