FDA Adverse Event
Malfunction
Summary report: N
MA204
MDR report key: 2933457
·
Received December 21, 2012
Report
- Report Number
- 1831750-2012-13159
- Event Type
- Malfunction
- Date Received
- December 21, 2012
- Date of Event
- December 1, 2012
- Report Date
- December 1, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
HEAD BOARD.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE HEADBOARD WAS CRACKED WITH REPORTED SHARP EDGE. THE CUSTOMER REPORTED THAT THEY DID NOT KNOW IF THERE WAS ANY PT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MA204 | A/C HOSPITAL BED | FNL | STRYKER MEDICAL | FL25E | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |