BEUDAMED
    FDA Adverse Event Injury Summary report: N

    J-VAC RESERVOIR

    MDR report key: 660531 · Received January 6, 2006

    Report

    Report Number
    2210968-2006-00026
    Event Type
    Injury
    Date Received
    January 6, 2006
    Date of Event
    October 14, 2005
    Report Date
    December 9, 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

    INTERNATIONAL AFFILIATE REPORTS THAT A PT UNDERWENT HEPATIC RESECTION IN 08/2005. IN WHICH A RESERVOIR WAS USED POST OP. THE PT WAS DISCHARGED TWO WEEKS LATER. AFFILIATE REPORTS THAT THAT THE PT DEVELOPED INTRA-ABDOMINAL ABSCESS AND WAS REHOSPITALIZED IN ABOUT 2 WEEKS. PT UNDERWENT PUNCTURE DRAINAGE AND ANTIBIOTIC ADMINISTRATION. PT WAS DISCHARGED THREE WEEKS LATER.

    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