BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRUTCHES ALUMINUM PUSH BUTTON

    MDR report key: 7568931 · Received June 5, 2018

    Report

    Report Number
    3005555653-2018-00001
    Event Type
    Malfunction
    Date Received
    June 5, 2018
    Date of Event
    April 15, 2018
    Report Date
    June 5, 2018
    Manufacturer
    CAREMAX REHABILITATION EQUIPMENT CO., LTD.
    Product Code
    IPR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS BEING ESCORTED TO HIS CAR WHEN THE LEFT CRUTCH BENT AND CAUSED HIM TO FALL TO THE GROUND. PATIENT NOW COMPLAINS OF SOME LEFT SHOULDER PAIN. PATIENT IS ABLE TO MOVE THE LEFT SHOULDER. PHYSICAL EXAM - NO BRUISING OR SWELLING. FULL LEFT SHOULDER ROM AND STRENGTH. COMPARTMENT SOFT WITH 2+RADIAL PULSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410558 CRUTCHES ALUMINUM PUSH BUTTON CRUTCH IPR CAREMAX REHABILITATION EQUIPMENT CO., LTD. 100309-000

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR