FDA Adverse Event
Malfunction
Summary report: N
SECURE II MED/SURG BED
MDR report key: 2231504
·
Received July 22, 2011
Report
- Report Number
- 1831750-2011-07497
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Date of Event
- June 26, 2011
- Report Date
- June 26, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT - CRACKED FOOTBOARD MODULES WITH BROKEN TABS.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE FOOTBOARD MODULES WERE CRACKED, AND THE TABS WERE BROKEN, WITH NO SHARP EDGES EXPOSED. IT IS UNK IF THERE WAS PT INVOLVEMENT. HOWEVER, NO ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SECURE II MED/SURG BED | A/C POWERED HOSPITAL BED | FNL | STRYKER MEDICAL | 3002 EX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |