BEUDAMED
    FDA Adverse Event Other Summary report: N

    CHANEL DRAIN 15FR, FULL FLUTED

    MDR report key: 1023763 · Received March 27, 2008

    Report

    Report Number
    8030107-2008-00001
    Event Type
    Other
    Date Received
    March 27, 2008
    Report Date
    March 17, 2008
    Manufacturer
    DEGANIA SILICONE, LTD.
    Product Code
    GCY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONTAINMENT ACTION HAS BEEN TAKEN. NO CORRECTIVE OR PREVENTIVE ACTION HAS BEEN TAKEN.

    Description of Event or Problem · 1

    WOUND DRAIN BROKE WHILE IN PATIENT, NOT DURING ATTEMPTED REMOVAL. REMAINDER HAD TO BE SURGICALLY REMOVED FROM INSIDE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHANEL DRAIN 15FR, FULL FLUTED SURGERY DRAIN GCY DEGANIA SILICONE, LTD. JP 2188 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention