BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHANNEL DRAIN

    MDR report key: 3874664 · Received April 24, 2014

    Report

    Report Number
    1018233-2014-00090
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Report Date
    April 1, 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

    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 A BREAST RECONSTRUCTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248308 CHANNEL DRAIN GBX PRODUCTOS PARA EL CUIDADO DE LA SALUD NA NGXL1209

    Patients

    Seq Age Sex Outcome Treatment
    1