FDA Adverse Event
Injury
Summary report: N
MAXI MOVE
MDR report key: 3022522
·
Received March 21, 2013
Report
- Report Number
- 9681684-2013-00016
- Event Type
- Injury
- Date Received
- March 21, 2013
- Date of Event
- February 18, 2013
- Report Date
- February 19, 2013
- Manufacturer
- ARJOHUNTLEIGH MAGOG INC
- Product Code
- FSA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY THE MFR (B)(4). ON BEHALF OF THE IMPORTER (B)(6). THE DEVICE WAS INSPECTED ON-SITE BY A REP OF THE MFR'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NOT A DIRECT EMPLOYEE OF THE MFR. ADDITIONAL INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.
Description of Event or Problem · 1
THE PT WAS BEING TRANSFERRED FROM HIS BED TO HIS WHEELCHAIR. TWO CAREGIVERS WERE IN POSITION AND HELPING WITH THE TRANSFER. THE PT WAS BUMPING THE SLING CLIP IN A WAY THAT THE CLIP COULD DETACH FROM THE HANGER BAR LOCKING PIN. HE WAS SLIDING OUT OF THE SLING, FELL TO THE FLOOR AND BUMPED HIS HEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 116918 | MAXI MOVE | MANUFACTURED FLOOR PASSIVE LIFT | FSA | ARJOHUNTLEIGH MAGOG INC | KMCLUN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |