BEUDAMED
    FDA Adverse Event Injury Summary report: N

    J-VAC RESERVOIR

    MDR report key: 663375 · Received January 12, 2006

    Report

    Report Number
    2210968-2006-00047
    Event Type
    Injury
    Date Received
    January 12, 2006
    Date of Event
    September 26, 2005
    Report Date
    October 5, 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 RESERVOIR WAS USED FOLLOWING FENESTRATION SURGERY IN 08/2005. THE PT WAS SUBSEQUENLTY DISCHARGED TWO WEEKS POST-OP. APPROX ONE MONTH POST OP THE PT PRESENTED WITH A BACKACHE AND FEVER. THE PT WAS HOSPITALIZED AND INTRAVENOUS ANTIBIOTIC THERAPY INITIATED. THE PT IS STILL IN THE HOSP.

    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 Required Intervention