BEUDAMED
    FDA Adverse Event Death Summary report: N

    WAIST AND CHEST JACKET

    MDR report key: 28348 · Received November 30, 1995

    Report

    Report Number
    MW1007800
    Event Type
    Death
    Date Received
    November 30, 1995
    Date of Event
    November 8, 1995
    Report Date
    November 20, 1995
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    FMQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE, MUNDELEIN, IL 60060-4486. AGAIN WER WERE DENIED BOTH REPORTS. OUR REVIEW OF THE INFO PROVIDED DOES NOT INDICATE DEVICE FAILURE. THE FACT THE PT WAS FOUND SITTING ON THE FLOOR INDICATES THAT THE INCIDENT MAY HAVE OCCURRED DUE TO USE/FITTING OF THE DEVICE OR A POSSIBLE MONITORING ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WAIST AND CHEST JACKET PATIENT RESTRAINT FMQ MEDLINE INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death