FDA Adverse Event Death Summary report: N

SECURE-ALL ONE PIECE BODY HOLDER

MDR report key: 204613 · Received December 18, 1998

Report

Report Number
204613
Event Type
Death
Date Received
December 18, 1998
Date of Event
November 26, 1998
Report Date
December 2, 1998
Manufacturer
TECNOL MEDICAL PRODUCTS, INC.
Product Code
FMQ
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
AZ, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

A 68 Y/O PT WAS FOUND DANGLING FROM SIDE OF BED WITH THE POSEY AROUND HER NECK. SMALL SIZE USED. PT WEIGHED BETWEEN 90 AND 100 POUNDS. HISTORY OF PROGRESSIVE DEMENTIA AND PNEUMONIA, DEHYDRATION AND RENAL FAILURE. WAS MADE A MEDICAL EXAMINER'S CASE AND CAUSE OF DEATH HAS YET TO BE DETERMINED. POLICE TOOK THE POSEY AS PART OF THEIR INVESTIGATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SECURE-ALL ONE PIECE BODY HOLDER POSEY FMQ TECNOL MEDICAL PRODUCTS, INC. * *

Patients

Seq Age Sex Outcome Treatment
1 68 YR Death