BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENAFLOW ELITE

    MDR report key: 3162481 · Received June 6, 2013

    Report

    Report Number
    2020737-2013-00002
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 13, 2013
    Report Date
    June 6, 2013
    Manufacturer
    DJO, LLC
    Product Code
    JOW
    PMA / PMN Number
    K0191700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER COMPLAINT STATING THAT THE PRODUCT WAS DAMAGED DUE TO A THERMAL MELTDOWN. THERE WAS NO PT AND/OR CARETAKER INVOLVEMENT WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251510 VENAFLOW ELITE VENAFLOW ELITE JOW DJO, LLC 30BI-B

    Patients

    Seq Age Sex Outcome Treatment
    1