BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRUTCHES

    MDR report key: 4634683 · Received February 19, 2015

    Report

    Report Number
    4634683
    Event Type
    Malfunction
    Date Received
    February 19, 2015
    Date of Event
    February 17, 2015
    Report Date
    February 19, 2015
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    INP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE THERAPIST WAS IN FRONT OF THE PATIENT AND THE ASSISTANT IN THE BACK OF THE PATIENT. PATIENT WAS USING THE RAIL AND A CRUTCH ON THE STEPS, COMING DOWN, AND THE CRUTCH CAME APART. THE TOP RUBBER AND ALUMINUM SEPARATED FROM THE WHOLE CRUTCH. THE CRUTCHES WERE NEW AND HAD JUST BEEN OPENED IN THE MORNING PT VISIT AND WERE JUST FINE AT THE TIME. THE PATIENT'S WEIGHT WAS LESS THAN 100 LBS. THE REHAB ASSISTANT WHO COMPLETED THIS REPORT HAS BEEN HERE FOR SEVERAL YEARS.======================MANUFACTURER RESPONSE FOR ALUMINUM CRUTCH, MEDLINE (PER SITE REPORTER).======================I TALKED TO QUALITY AND SAID I HAD THE CRUTCH TO SEND BACK. THEY ASKED ME TO SEND A PICTURE AND I TOLD HIM I WANTED TO SEND THE ACTUAL CRUTCH FOR INVESTIGATION. THEY ARE SENDING ME A SHIPPING LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121204 CRUTCHES TIPS AND PADS, CANE, CRUTCH AND WALKER INP MEDLINE INDUSTRIES, INC. MDSV80535 140866702

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES