BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHANNEL DRAIN

    MDR report key: 3874662 · Received April 24, 2014

    Report

    Report Number
    1018233-2014-00089
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Report Date
    April 1, 2014
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    GBX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 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 DRAIN BROKE NEAR THE TROCAR DURING BREAST RECONSTRUCTION. THE DRAIN WAS VERY DIFFICULT TO PULL THROUGH THE SKIN WHERE THE DRAIN IS ATTACHED TO THE TROCAR. THE SURGEON HAD TO USE GREAT FORCE IN ORDER TO PASS THE TROCAR THROUGH THE SKIN. THE DRAIN TUBE TORE AND IS PARTIALLY OFF THE TROCAR DUE TOT HE FORCE APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248350 CHANNEL DRAIN GBX PRODUCTOS PARA EL CUIDADO DE LA SALUD NA NGXJ0245

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR