FDA Adverse Event
Malfunction
Summary report: N
SECURE 3 MED/SURG BED
MDR report key: 2222480
·
Received July 13, 2011
Report
- Report Number
- 1831750-2011-07025
- Event Type
- Malfunction
- Date Received
- July 13, 2011
- Date of Event
- June 15, 2011
- Report Date
- June 15, 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 MATTRESS RETAINER WAS BROKEN WITH A SHARP EDGE. THE CUSTOMER COULD NOT DETERMINED IF THERE WAS PT 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 |