FDA Adverse Event
Injury
Summary report: N
EASY CARE SERIES BED
MDR report key: 3030622
·
Received March 25, 2013
Report
- Report Number
- 3009402404-2013-00014
- Event Type
- Injury
- Date Received
- March 25, 2013
- Date of Event
- February 26, 2013
- Report Date
- March 25, 2013
- Manufacturer
- JOERNS HEALTHCARE
- Product Code
- FNL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
JOERNS SENDING REPORT TO MANUFACTURER.
Description of Event or Problem · 1
IT WAS REPORTED TO THE MANUFACTURER BY THE FACILITY ((B)(6)), PER FACILITY, THE VISITOR OF THE RESIDENT WAS STANDING AT THE FOOT OF THE BED. THE RESIDENT WAS LIFTING THE BED UP, BY USE OF THE CONTROLS. THE BED SNAPPED AND FELL DOWN. THE BED LANDED ON THE VISITOR'S TOE. THE FACILITY ((B)(4)) CALLED 911 AND THE VISITOR WAS TRANSPORTED TO THE EMERGENCY ROOM. AN X-RAY WAS PERFORMED TO DETERMINE THAT THE TOE WAS FRACTURED. COMPLAINT (B)(4) WAS ENTERED INTO OUR SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 121430 | EASY CARE SERIES BED | ELECTRIC PATIENT BED | FNL | JOERNS HEALTHCARE | B330 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Required Intervention |