FDA Adverse Event
Injury
Summary report: N
3002 MASTER BOMS
MDR report key: 3911462
·
Received July 3, 2014
Report
- Report Number
- 0001831750-2014-03128
- Event Type
- Injury
- Date Received
- July 3, 2014
- Date of Event
- June 12, 2014
- Report Date
- June 12, 2014
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION DETERMINED THE LOCKING MECHANISM WAS DAMAGED AND SHOWED SIGNS OF IMPACT.
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT WHILE EXITING THE BED, A PATIENT WAS ALLEGEDLY INJURED HOLDING ONTO THE SIDERAIL FOR SUPPORT AND IT COLLAPSED. THE PATIENT ALLEGEDLY SUFFERED A LACERATION TO THE LEFT HAND; HOWEVER, NO STITCHES WERE REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 389314 | 3002 MASTER BOMS | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |