BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3013904 · Received March 20, 2013

    Report

    Report Number
    1531186-2013-01182
    Date Received
    March 20, 2013
    Report Date
    February 22, 2013
    Manufacturer
    DANYANG MAXTHAI MEDICAL EQUIPMENT
    Product Code
    IOR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. CUSTOMER CALLED AND FOLD DOWN LEVER ON THE LEFT SIDE IS BROKEN AND WILL NOT TIGHTEN, OR KEEP THE BACK CANE UP. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115695 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR DANYANG MAXTHAI MEDICAL EQUIPMENT ARL19HBFR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other