BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICHOICE

    MDR report key: 5439070 · Received February 16, 2016

    Report

    Report Number
    3003753847-2016-00001
    Event Type
    Malfunction
    Date Received
    February 16, 2016
    Date of Event
    September 24, 2015
    Report Date
    February 16, 2016
    Manufacturer
    CAREMAX REHABILITATION EQUIPMENT CO., LTD.
    Product Code
    IPR
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OWENS & MINOR DISTRIBUTION, INC., THE INITIAL IMPORTER AND PRIVATE-LABEL DISTRIBUTOR OF THE MEDICHOICE CRUTCH, RECEIVED A PRODUCT PROBLEM REPORT FROM A USER FACILITY. THE USER FACILITY REPORTED THAT THE WING NUT ON ONE CRUTCH PROVIDED TO ONE OF THEIR PATIENTS CAME LOOSE ON THE HAND GRIP CAUSING THE PATIENT TO FALL. THE FALL OCCURRED AWAY FROM THE USER FACILITY. THE PATIENT WAS EXAMINED AT THE HOSPITAL WHERE THEY RECEIVED THE CRUTCH. NO INJURY OCCURRED AS A RESULT OF THE FALL, AND NO MEDICAL INTERVENTION WAS REQUIRED TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96430 MEDICHOICE CRUTCH IPR CAREMAX REHABILITATION EQUIPMENT CO., LTD. 77708A CM1502 037576

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR