FDA Adverse Event
Injury
Summary report: N
MAXI 500
MDR report key: 3080735
·
Received April 11, 2013
Report
- Report Number
- 1419652-2013-00092
- Event Type
- Injury
- Date Received
- April 11, 2013
- Date of Event
- March 19, 2013
- Report Date
- March 19, 2013
- Manufacturer
- ARJOHUNTLEIGH MAGOG INC
- Product Code
- FSA
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CAREGIVER ASSISTED THE RESIDENT TO BE TRANSFERRED FROM WHEELCHAIR TO HER BED. WHEN CAREGIVER RAISED THE RESIDENT FROM WHEELCHAIR, SHE NOTICED THAT THE WHEELCHAIR RAISED AS WELL. THE CAREGIVER PLACED A HAND ON THE LIFTING ARM HANDLE AND PUSHED DOWN ON THE WHEELCHAIR WITH HER OTHER HAND. AS THE WHEELCHAIR WENT DOWN DUE TO CAREGIVER PUSHING IT DOWN, THE RESIDENT'S WEIGHT SHIFTED FORWARD, TOWARDS THE LOWER BAR OF LIFTING ARM. THIS CAUSED THE SLING AND/OR THE BAR TO PRESS TIGHT AGAINST HER GROIN AREA, CAUSING AN INJURY. PLEASE REF MFR #9681684-2013-00033.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 156380 | MAXI 500 | MANUFACTURED FLOOR PASSIVE LIFT | FSA | ARJOHUNTLEIGH MAGOG INC | KM560181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Hospitalization |