BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACARE VEST STYLE BOBY HOLDER WITH SAFETY SLEEVES

    MDR report key: 46074 · Received October 31, 1996

    Report

    Report Number
    8030643-1996-00002
    Event Type
    Malfunction
    Date Received
    October 31, 1996
    Date of Event
    October 3, 1996
    Report Date
    October 29, 1996
    Manufacturer
    TECNOL MEDICAL PRODUCTS, INC.
    Product Code
    FMQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS WEARING A POSEY VEST. SHE SLID DOWN INTO THE SEAT OF A WHEELCHAIR AND THE SEATBELT WAS AROUND HER CHEST; WHEN THE NURSE FOUND HER SHE WASS CYANOTIC; SEATBELT WAS RELEASED TO FREE THE PT. PT WAS CHECKED BY PHYSICIAN WHO NOTED A RED SPOT ON HER POSTERIOR. PT WAS RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACARE VEST STYLE BOBY HOLDER WITH SAFETY SLEEVES WHEELCHAIR FMQ TECNOL MEDICAL PRODUCTS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening