BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPORT 20 IN X 16 IN 9153637574

    MDR report key: 5104604 · Received September 25, 2015

    Report

    Report Number
    9616091-2015-02340
    Event Type
    Malfunction
    Date Received
    September 25, 2015
    Report Date
    August 28, 2015
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    DEALER STATES THE RIGHT CROSSBRACE HAS BROKEN TOWARD THE WELDMENT WHERE IT ATTACHES TO THE SEAT RAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635537 TRANSPORT 20 IN X 16 IN 9153637574 WHEELCHAIR, MECHANICAL IOR INVAMEX 9XDT

    Patients

    Seq Age Sex Outcome Treatment
    1