BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3243376 · Received July 23, 2013

    Report

    Report Number
    1531186-2013-03310
    Date Received
    July 23, 2013
    Report Date
    July 3, 2013
    Manufacturer
    TAIWAN ANI CO., LTD.
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ISSUED MFR. REPORT # 1531186-2013-03310 INDICTING THE AWARENESS DATE AS (B)(4) 2013 AND THE DUE DATE AS (B)(4) 2013. THE CORRECT DATE OF THIS REPORT AND DATE FACILITY / IMPORTER WAS AWARE IS (B)(4) 2013. THE CORRECT DUE DATE IS (B)(4) 2013, SUBMISSION WAS MADE ON (B)(4) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SEAT FRAME ON THE IN08AHANFR MANUAL WHEELCHAIR HAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344505 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR TAIWAN ANI CO., LTD. IN08AHANFR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other