BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPORT 20 IN X 16 IN 9153637574

    MDR report key: 4892111 · Received July 6, 2015

    Report

    Report Number
    9616091-2015-01759
    Event Type
    Malfunction
    Date Received
    July 6, 2015
    Report Date
    June 10, 2015
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    THE DEALER STATES THAT THE CHAIR IS RUSTED AND THE WELD BROKE ON THE LEFT HAND SIDE UNDER THE SEAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436700 TRANSPORT 20 IN X 16 IN 9153637574 WHEELCHAIR, MECHANICAL IOR INVAMEX T420RDA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other