FDA Adverse Event
Injury
Summary report: N
INVACARE LIFTS AND SLINGS
MDR report key: 1053350
·
Received May 28, 2008
Report
- Report Number
- 1525712-2008-00044
- Event Type
- Injury
- Date Received
- May 28, 2008
- Date of Event
- May 5, 2008
- Report Date
- May 19, 2008
- Manufacturer
- INVACARE CORPORATION - MANUFACTURING FACILITY
- Product Code
- FSA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
DEVICE HAS BEEN IN USE FOR 8 YEARS AND IS NO LONGER IN WARRANTY. INFORMATION INDICATES A POTENTIAL TRANSFER ERROR. UNCLEAR IF PROPER MAINTENANCE HAS BEEN PERFORMED ON THE LIFT PRIOR TO ALLEGED INCIDENT. MDR FILED BASED ON SERIOUS INJURY CLAIM.
Description of Event or Problem · 1
THE CAREGIVER ALLEGEDLY TRIED TO USE THE LIFT TO LIFT THE CONSUMER, WITHOUT OPENING THE BASE, CAUSING THE LIFT TO TIP OVER THE CONSUMER. THIS ALLEGEDLY RESULTED IN 30 STITCHES TO THE CONSUMER'S FOREHEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INVACARE LIFTS AND SLINGS | 880.5510 | FSA | INVACARE CORPORATION - MANUFACTURING FACILITY | RPL450-1 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |