BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2884493 · Received December 22, 2012

    Report

    Report Number
    1531186-2012-01849
    Date Received
    December 22, 2012
    Report Date
    December 21, 2012
    Manufacturer
    ANI [ A&I ] GROUP TAIWAN
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4) - THE DEALER REPORTED THAT THE IN86AHANFR MECHANICAL WHEELCHAIR HAD BOTH PIVOT LINKS BROKEN. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR ANI [ A&I ] GROUP TAIWAN IN86AHANFR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other