BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRSX5RC/WD66/28/R/U240 9153641587

    MDR report key: 4843402 · Received June 15, 2015

    Report

    Report Number
    9616091-2015-01580
    Event Type
    Malfunction
    Date Received
    June 15, 2015
    Report Date
    May 21, 2015
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A RETURNED WAS ISSUED AND THE PRODUCT IS AWAITING RECEIPT AND/OR EVALUATION. A FOLLOW UP WILL BE FILED IF/WHEN ANY ADDITIONAL INFORMATION IS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER JUST TOOK THIS OUT OF THE BOX TODAY AND REALIZED THAT THERE IS A BROKEN WELD IN THE FRAME OF THE CHAIR. IT IS WHERE THE CROSSBAR WOULD BE MOUNTED TO THE TOP OF THE WHEELCHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387337 TRSX5RC/WD66/28/R/U240 9153641587 WHEELCHAIR, MECHANICAL IOR INVAMEX TRSX5RC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other