BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHANNEL DRAIN, HUBLESS FULL FLUTE WITH TROCAR

    MDR report key: 3831858 · Received March 6, 2014

    Report

    Report Number
    1018233-2014-00054
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Report Date
    February 11, 2014
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    GBX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TROCAR WAS NOT SHARP ENOUGH AND THE TRANSITION BETWEEN THE TROCAR AND DRAIN SEEMS TO CAUSE DRAG. DOCTOR FEELS HE HAS TO FORCE THE TROCAR THROUGH THE SKIN. PRODUCT BEING USED FOR BREAST CONSTRUCTION. DRAIN BROKE DURING PASS THROUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134909 CHANNEL DRAIN, HUBLESS FULL FLUTE WITH TROCAR GBX PRODUCTOS PARA EL CUIDADO DE LA SALUD NA NGXK1816

    Patients

    Seq Age Sex Outcome Treatment
    1