BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E.M ADAMS CO, INC.

    MDR report key: 21468415 · Received February 26, 2025

    Report

    Report Number
    21468415
    Event Type
    Malfunction
    Date Received
    February 26, 2025
    Date of Event
    January 23, 2025
    Report Date
    January 23, 2025
    Manufacturer
    E.M. ADAMS CO., INC.
    Product Code
    FMQ
    UDI-DI
    10840200304242
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS ABLE TO BREAK BOTH SOFT WRIST RESTRAINTS AWAY FROM THE BED AND SELF EXTUBATED DESPITE INTERVENTIONS OF BEDSIDE RN AND RESPIRATORY THERAPIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659106 E.M ADAMS CO, INC. RESTRAINT, PROTECTIVE FMQ E.M. ADAMS CO., INC. 26-0692 11-24 10840200304242

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male