FDA Adverse Event
Injury
Summary report: N
INVACARE LIFTS AND SLINGS
MDR report key: 1073663
·
Received July 9, 2008
Report
- Report Number
- 1525712-2008-00061
- Event Type
- Injury
- Date Received
- July 9, 2008
- Date of Event
- May 25, 2008
- Report Date
- July 7, 2008
- Manufacturer
- INVACARE CORPORATION - MANUFACTURING FACILITY
- Product Code
- FSA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE HAS BEEN IN USE FOR 7 YEARS WITH NO REPORTED INCIDENTS AND IS NO LONGER IN WARRANTY. DURING TRANSFER USER CAME IN CONTACT WITH THE PUMP LEVER RESULTING IN ALLEGED INJURY. DEALER INSPECTED THE DEVICE AND REPORTS NO SHARP EDGES. CURRENT USER GUIDE COVERS PROPER TRANSFER METHODS. DEVICE REMAINS IN USE. MDR FILED BASED ON ALLEGED INJURY.
Description of Event or Problem · 1
THE CONSUMER WAS BEING TRANSFERRED FROM HER BED TO THE WHEELCHAIR, WHEN SHE ALLEGEDLY CUT HER LEFT LEG ON THE TOP OF THE HYDRAULIC PUMP. NO SERIOUS INJURY IS ALLEGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INVACARE LIFTS AND SLINGS | 880.5510 | FSA | INVACARE CORPORATION - MANUFACTURING FACILITY | 9805 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |