BEUDAMED
    FDA Adverse Event Summary report: N

    WHEELCHAIR COMPONENTS

    MDR report key: 3133047 · Received May 29, 2013

    Report

    Report Number
    1531186-2013-02330
    Date Received
    May 29, 2013
    Report Date
    October 26, 2012
    Manufacturer
    JUMAO MEDICAL EQUIPMENT
    Product Code
    KNN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INVACARE AWARENESS DATE (10/26/2012). COMPLAINT WAS NOT GIVEN TO REGULATORY AFFAIRS FROM CUSTOMER SERVICE FOR PROCESSING UNTIL (05/22/2013). POTENTIAL FOR INJURY ASSOCIATED WITH THE CLIP BEING BROKEN ON THE FOOTREST ON AN T93HE MANUAL WHEELCHAIR THIS COULD CAUSE INSTABILITY WITH THE PRODUCT.

    Description of Event or Problem · 1

    THE DEALER IS REPORTING THAT THE CLIP IS BROKEN ON THE FOOTREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235237 WHEELCHAIR COMPONENTS 890.3920 KNN JUMAO MEDICAL EQUIPMENT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other