BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T4/WD2418/HD/ADULT/28/BH16/AT903/U2222C/COM/U550 9153639569

    MDR report key: 4894220 · Received July 7, 2015

    Report

    Report Number
    9616091-2015-01767
    Event Type
    Malfunction
    Date Received
    July 7, 2015
    Report Date
    June 10, 2015
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP WILL BE SENT IF THE PRODUCT OR ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    DEALER IS STATING THAT THE CHAIR HAS A BROKEN WELD IN THE BACK OF THE FRAME NEAR WHERE THE ANTI-TIPPERS ATTACH, ON THE LEFT SIDE WHEN SITTING IN THE CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438361 T4/WD2418/HD/ADULT/28/BH16/AT903/U2222C/COM/U550 9153639569 WHEELCHAIR, MECHANICAL IOR INVAMEX T424RDA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other