FDA Adverse Event
Malfunction
Summary report: N
SECURE 3 MED/SURG BED
MDR report key: 2233001
·
Received July 25, 2011
Report
- Report Number
- 1831750-2011-07582
- Event Type
- Malfunction
- Date Received
- July 25, 2011
- Date of Event
- June 27, 2011
- Report Date
- June 27, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
RESULT: FOOTBOARD.
Description of Event or Problem · 1
IT WAS REPORTED BY SVC REPORT THAT THE FOOTBOARD WAS BROKEN AND THERE WERE SHARP EDGES. THE CUSTOMER COULD NOT DETERMINE IF THERE WAS PT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT.
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 |