BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2862828 · Received December 10, 2012

    Report

    Report Number
    1531186-2012-01655
    Date Received
    December 10, 2012
    Report Date
    December 6, 2012
    Manufacturer
    ANI [ A&I ] GROUP TAIWAN
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    AN END USER STATES THAT WHILE SITTING IN CHAIR THE RIGHT SIDE CROSSBRACE BROKE AT CENTER HOLE WHERE BOTH CROSSBRACES CONNECT AND CROSSOVER. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR ANI [ A&I ] GROUP TAIWAN IN88AHANFR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other