BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE WRIST/ANKLE LIMB HOLDER W/ LOCK

    MDR report key: 23545454 · Received November 12, 2025

    Report

    Report Number
    MW5178861
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    November 6, 2025
    Report Date
    November 11, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP - NORTHFIELD
    Product Code
    FMQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT BEING MONITORED IN RM AND WAS PLACED IN MEDLINE TWICE AS TOUGH RESTRAINTS FOR SAFETY. PATIENT ABLE TO HIT RESTRAINT MULTIPLE TIMES ON BEDFRAME, WITH MINIMAL EFFORT AND STRENGTH, AND THE TWICE AS TOUCH MENTAL RESTRAINT CLASP/LOCKING MECHANISM WOULD BREAK OPEN. REPLACED THE RESTRAINS AND TRIED ANOTHER SET AND PATIENT WAS ABLE TO BREAK FREE AGAIN. PATIENT BROKE OUT OF ALL RESTRAINTS (WRISTS AND ANKLES) MULTIPLE TIMES BY HITTING AGAINST THE BED UNTIL METAL LOCK FAILED AND BROKE OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1922938 MEDLINE WRIST/ANKLE LIMB HOLDER W/ LOCK RESTRAINT, PROTECTIVE FMQ MEDLINE INDUSTRIES, LP - NORTHFIELD MDT829098W 3302505001

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Other