BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2874646 · Received December 15, 2012

    Report

    Report Number
    1531186-2012-01757
    Date Received
    December 15, 2012
    Report Date
    December 14, 2012
    Manufacturer
    ANI [ A&I ] GROUP TAIWAN
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    MDR DECISION DATE: (B)(6) - NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATES ALLEGEDLY UNDER THE CHAIR WHERE THE CROSSBRACE IS, THE FRAME IS BROKEN. THE CHAIR COLLAPSES FOR FOLDING. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR ANI [ A&I ] GROUP TAIWAN IN66AHANFR

    Patients

    Seq Age Sex Outcome Treatment
    1 62 Other