BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUBLESS SILICONE FLAT DRAIN

    MDR report key: 3801686 · Received April 28, 2014

    Report

    Report Number
    1018233-2014-00095
    Event Type
    Injury
    Date Received
    April 28, 2014
    Report Date
    April 3, 2014
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    GBX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 15 FRENCH DRAIN WAS PLACED IN THE LOWER LEFT QUADRANT OF THE PATIENT'S ABDOMEN AND TIED INTO PLACE USING 3-0 VICRYL SUTURE. TWO DAYS LATER, THE DOCTOR ATTEMPTED TO REMOVE THE JP DRAIN. THE SUTURE WAS REMOVED. WITH STEADY, DIRECT PRESSURE, THE TUBE WAS PULLED AND BROKE APPROXIMATELY 5 CM ABOVE THE TIE. THUS, THE JP REMAINING SEGMENT WAS THEN INTRA-ABDOMINAL. THE PT HAD TO RETURN TO SURGERY FOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253353 HUBLESS SILICONE FLAT DRAIN GBX PRODUCTOS PARA EL CUIDADO DE LA SALUD NA NGXH4132

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention