FDA Adverse Event
Injury
Summary report: N
INVACARE LIFTS AND SLINGS
MDR report key: 1193434
·
Received September 30, 2008
Report
- Report Number
- 1525712-2008-00090
- Event Type
- Injury
- Date Received
- September 30, 2008
- Manufacturer
- INVACARE CORP.
- Product Code
- FNG
- Report Source
- Manufacturer report
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
MFR REC'D UF/IMPORTER REPORT. CONSUMER REPORTEDLY WAS BEING TRANSFERRED AND THE SLING LOOP CAME OFF THE HOOK. NO SERIAL NUMBER HAS BEEN PROVIDED. AGE OF THE DEVICE AND MAINTENANCE HISTORY IS UNK. THE COMPLAINT, AS REC'D, INDICATES THAT THE LOOP OF THE SLING SOMEHOW BECAME DETACHED FROM THE SPREADER BAR HOOK DURING TRANSFER OF THE PT. PROPERLY USED, SLING LOOPS WILL NOT COME OFF THE HOOK AS DESCRIBED. USER GUIDES ARE CLEAR IN INSTRUCTING AS TO THE PROPER AND SAFE USE OF THE PROD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INVACARE LIFTS AND SLINGS | * | FNG | INVACARE CORP. | RPL 450-1 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |