FDA Adverse Event
Malfunction
Summary report: N
SECURE 2 MED/SURGBED
MDR report key: 2091010
·
Received May 11, 2011
Report
- Report Number
- 1831750-2011-04524
- Event Type
- Malfunction
- Date Received
- May 11, 2011
- Date of Event
- April 13, 2011
- Report Date
- April 13, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULT: MULTIPLE IMPACTS DAMAGED THE HEAD RIGHT SIDERAIL ASSEMBLY.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE HEAD RIGHT SIDERAIL WAS BROKEN. 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 2 MED/SURGBED | A/C POWERED HOSPITAL BED | FNL | STRYKER MEDICAL | 3002 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |