BEUDAMED
    FDA Adverse Event Injury Summary report: N

    J-VAC RESERVOIR

    MDR report key: 660521 · Received January 6, 2006

    Report

    Report Number
    2210968-2006-00010
    Event Type
    Injury
    Date Received
    January 6, 2006
    Date of Event
    September 3, 2005
    Report Date
    October 27, 2005
    Manufacturer
    ETHICON, INC.
    Product Code
    GCY
    Removal / Correction Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A PT DEVELOPED AN INFECTION FIVE DAYS FOLLOWING MOUTH MALIGNANCY RESECTION, MANDIBULECTOMY, LEFT LYMPH NODE DISSECTION AND PECTORALIS MAJOR MUSCLE FLAP RECONSTRUCTION PERFORMED IN 08/2005. DEVICE WITH ATTACHED DRAIN WAS USED POST OP. FIVE DAYS LATER PUS DISCHARGE WAS OBSERVED FROM THE AREA OF THE LEFT CLAVICLE. ANTIOBIOTIC WAS ADMINISTERED AND THE WOUND WAS WASHED TWICE A DAY AND COVERED WITH FRESH GAUZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J-VAC RESERVOIR WOUND DRAINAGE SYSTEM GCY ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN