BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA CARE VEST STYLE BODY HOLDER

    MDR report key: 137710 · Received November 7, 1997

    Report

    Report Number
    137710
    Event Type
    Malfunction
    Date Received
    November 7, 1997
    Date of Event
    September 8, 1997
    Report Date
    October 9, 1997
    Manufacturer
    TECNOL MEDICAL PRODUCTS, INC.
    Product Code
    FMQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    VEST RESTRAINT PLACED ON PT WHILE SITTING IN A CHAIR. PT FOUND APPROX 15 MINUTES LATER SLID DOWN FROM CHAIR ONTO THE FLOOR WITH THE VEST RESTRAINT CAUGHT AROUND PT'S NECK. PT'S FACE AND UPPER EXTREMITIES CYANOTIC. PT CRYING. PT RETURNED TO BED AND OXYGEN APPLIED. COLOR RETURNED TO NORMAL. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRA CARE VEST STYLE BODY HOLDER PROTECTIVE RESTRAINT FMQ TECNOL MEDICAL PRODUCTS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR