FDA Adverse Event
Injury
Summary report: N
DRIVE
MDR report key: 7365635
·
Received March 22, 2018
Report
- Report Number
- MW5076017
- Event Type
- Injury
- Date Received
- March 22, 2018
- Date of Event
- March 15, 2018
- Report Date
- March 21, 2018
- Manufacturer
- MEDICAL DEPOT INC. / DRIVE DEVILBISS HEALTHCARE
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
RESIDENT BEING TRANSFER OOB TO HER CARE FOAM CHAIR WITH AN INVACARE FULL MECHANICAL LIFT. RESIDENT HOISTED ABOVE BED IN LIFT SLING. SLING IN USE WAS A DRIVE MANUFACTURED SLING. SLING ATTACHED WITH ALL 4 STEPS TO LIFT. SLING CHECKED FOR DEFICITS BY STAFF PRIOR TO USE, NONE FOUND. RESIDENT MOVED TOWARDS CHAIR IN LIFT, STRAP ABOVE RIGHT SHOULDER RIPPED APART FROM SLING AND RESIDENT FELL TO FLOOR. INJURY OCCURRED WITH LARGE LACERATION TO RIGHT ARM. RESIDENT SENT TO ER FOR TREATMENT. ALL XRAYS NEGATIVE FOR FRACTURE, BUT DID RECEIVE SUTURES TO REPAIR LACERATION TO RIGHT ARM. DIAGNOSIS OR REASON FOR USE: NONAMBULATORY AND UNABLE TO PERFORM SAFE STAND OR TRANSFER. "IS THE PRODUCT COMPOUNDED: NO, IS THE PRODUCT OVER-THE-COUNTER: NO."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204182 | DRIVE | LIFT SLING | FSA | MEDICAL DEPOT INC. / DRIVE DEVILBISS HEALTHCARE | 1322 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Hospitalization |