FDA Adverse Event
Death
Summary report: N
TECNOL SECURE - ALL
MDR report key: 227137
·
Received June 10, 1999
Report
- Report Number
- 227137
- Event Type
- Death
- Date Received
- June 10, 1999
- Date of Event
- May 10, 1999
- Report Date
- June 9, 1999
- Manufacturer
- TECNOL, INC.
- Product Code
- FMQ
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- AZ, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
ON 5/10/99 PT FOUND IN HOSPITAL ROOM ON FLOOR KNEELING WITH ARMS CROSSED ON SIDE OF BED. POSEY VEST ON PT AS SHE WAS FOUND ON OPPSITE SIDE OF SIDERAILS (4 UP) WITH RESTRAINT REMAINING TIED TO BED. PT UNRESPONSIVE, NO RESPIRATIONS OR HEART BEAT. PT WAS CODED AND TRANSFERRED TO SUB-ACUTE CARE UNIT ON VENTILATOR. ON 5/11 PT EXTUBATED AND EXPIRED. UNKNOWN CAUSE OF DEATH WHETHER ATTRIBUTED TO POSEY VEST WAS NOT ACCEPTED AS MEDICAL EXAMINER CASE FOR AUTOPSY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TECNOL SECURE - ALL | BODYHOLDER | FMQ | TECNOL, INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Death |