FDA Adverse Event
Malfunction
Summary report: N
SECURE 3 MED/SURG BED
MDR report key: 2141371
·
Received June 1, 2011
Report
- Report Number
- 1831750-2011-05330
- Event Type
- Malfunction
- Date Received
- June 1, 2011
- Date of Event
- May 5, 2011
- Report Date
- May 5, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
RESULT: FOOT BOARD.
Description of Event or Problem · 1
IT WAS REPORTED BY SVC REPORT THAT THE FOOTBOARD WAS BROKEN INTO TWO PIECES AND THERE WERE SHARP EDGES AND FLUID INGRESS WAS POSSIBLE. IT WAS REPORTED THAT THE FLUID INGRESS WAS POSSIBLE. IT WAS REPORTED THAT THE CUSTOMER DOES NOT KNOW IF THERE WAS ANY PT INVOLVEMENT; HOWEVER, NO ADVERSE CONSEQUENCE WAS REPORTED RELATED TO THE ALLEGED ISSUE.
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 |