FDA Adverse Event
Summary report: N
SLEEVED JACKET
MDR report key: 85145
·
Received February 15, 1995
Report
- Report Number
- 85145
- Date Received
- February 15, 1995
- Date of Event
- September 28, 1994
- Report Date
- February 3, 1995
- Manufacturer
- SKIL-CARE CORP.
- Product Code
- FMQ
- Report Source
- User Facility report
- Reporter Location
- GA, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
PT WAS SITTING IN HER ROOM IN A WHEELCHAIR, RESTRAINED BY A SLEEVED JACKET, 4-POINT RESTRAINT WITH ZIPPERED BACK, WHICH HAD BEEN ORDERED BY HER ATTENDING PHYSICIAN. AT APPROX 7:40 A.M. ON 9/28/94, SHE WAS DISCOVERED WITH HER WHEELCHAIR TURNED PARTIALLY OVER AND THE PT IN A SITTING POSITION, HALF ON THE FLOOR AND HALF IN THE WHEELCHAIR, FACING FORWARD. THE VEST RESTRAINT HAD SIFTED UPWARD AROUND HER NECK, RESULTING IN COMPRESSIVE NECK INJURIES. CPR WAS IMMEDIATELY STARTED UPON DISCOVERY AND CONTINUED UNTIL STOPPED ON ORDERS OF THE ATTENDING PHYSICIAN. CORONER WAS CALLED AND CAME IMMEDIATELY TO THE NURSING HOME, WHERE HE PRONOUNCED THE PT DEAD. HE SENT THE BODY FOR AUTOPSY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SLEEVED JACKET | 4-POINT RESTRAINT WITH ZIPPERED BACK | FMQ | SKIL-CARE CORP. | 3050 MEDIUM | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR |