FDA Adverse Event
Injury
Summary report: N
MULTILIFT 200
MDR report key: 2343529
·
Received November 14, 2011
Report
- Report Number
- 3005536958-2011-00003
- Event Type
- Injury
- Date Received
- November 14, 2011
- Date of Event
- October 18, 2011
- Report Date
- November 14, 2011
- Manufacturer
- HANDICARE, AB
- Product Code
- FSA
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PT IS (B)(6). PT'S LEGS ARE BIG AND LEFT LEG ROTATES EXTERNALLY. AFTER PT WAS LIFTED UP IN SIT-TO STAND LIFT, HIS LEG PUSHED THE CORNER OF THE PAD INWARD WHERE HIS SKIN WAS THEN TORN ON THE METAL FRAME OF THE SHIN PAD LACERATING THE SKIN REQUIRING 27 STITCHES. PT'S LEG WAS INJURED DUE TO HIS LEG ROTATING AND BOWING OUTWARDS AND THAT THERE WAS NO FAULT WITH THE LIFT. CO REP INSPECTED LIFT AND FOUND NOTHING WRONG WITH LIFT. REP EXPLAINED THAT THE PT'S LEGS MUST BE CENTERED IN THE SHIN PAD. APPARENT CAUSE OF INJURY WAS DUE TO USER ERROR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTILIFT 200 | PATIENT LIFT | FSA | HANDICARE, AB | MINILIFT 200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |