BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN ALUMINUM CRUTCH

    MDR report key: 9238634 · Received October 25, 2019

    Report

    Report Number
    9238634
    Event Type
    Malfunction
    Date Received
    October 25, 2019
    Date of Event
    September 24, 2019
    Report Date
    October 1, 2019
    Manufacturer
    MEDLINE INDUSTRIES INC
    Product Code
    IPR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    EMPLOYEE HAD SUSTAINED AN INJURY TO ANKLE WHILE WORKING AND WAS PROVIDED WITH CRUTCHES TO USE. WHEN EMPLOYEE RETURNED TO EMPLOYEE HEALTH OFFICE, THE HANDLE OF ONE OF THE CRUTCHES FELL OFF FROM THE CRUTCH FRAME, POSSIBLE DUE TO A DEFECTIVE SCREW THAT ATTACHED HANDLE TO THE CRUTCH FRAME. IT WAS NOTED THAT THERE WAS NOT A WHITE PLASTIC WASHER WITH THE SCREW THAT CAME LOOSE FROM THE CRUTCH FRAME. EMPLOYEE DID NOT SUSTAIN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033356 GUARDIAN ALUMINUM CRUTCH CRUTCH IPR MEDLINE INDUSTRIES INC 6451906000

    Patients

    Seq Age Sex Outcome Treatment
    1