BEUDAMED
    FDA Adverse Event Death Summary report: N

    NA

    MDR report key: 159744 · Received March 27, 1998

    Report

    Report Number
    MW1013382
    Event Type
    Death
    Date Received
    March 27, 1998
    Date of Event
    December 12, 1997
    Report Date
    March 27, 1998
    Manufacturer
    NA
    Product Code
    FMQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE RPTR IS A STATE INSPECTOR. UPON VISITING THE FACILITY IN 1997, THE INSPECTION TEAM NOTED SOFT WAIST RESTRAINTS OF AN UNK DESIGN WERE BEING USED ON THE SKILLED NURSING UNIT. THE TEAM INQUIRED ABOUT THESE DEVICES AND ASCERTAINED THE USER FACILITY MAKES THEIR OWN RESTRAINTS. NO LABELLING OR INSTRUCTIONS FOR USE WERE AVAILABLE. NO STANDARD APPLICATION PROCESS WAS BEING USED. UPON FURTHER INQUIRY, THE TEAM LEARNED OF A PT DEATH WHICH OCCURRED IN 1997 AND WAS ASSOCIATED WITH THE DEVICE. A PT WAS FOUND TO HAVE SLIPPED DOWN THROUGH THE DEVICE WITH THE RESTRAINT CONSTRICTING HIS CHEST WHICH RESULTED IN HIS DEATH. THE DEATH WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA SOFT WAIST RESTRAINT FMQ NA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death