BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHEELCHAIR

    MDR report key: 4952951 · Received September 30, 2013

    Report

    Report Number
    9612393-2013-00106
    Event Type
    Malfunction
    Date Received
    September 30, 2013
    Report Date
    September 30, 2013
    Manufacturer
    TAIWAN AN I CO.,LTD.
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER IMPORTER'S MDR: (B)(6) 2013 - RBS - IT WAS REPORTED BY THE CONSUMER THAT THE IN86AHANFR MECHANICAL WHEELCHAIR BACK CANE WAS BROKEN. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494194 WHEELCHAIR IOR TAIWAN AN I CO.,LTD. IN86AHANFR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other