BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE-TEX SUTURE CV7

    MDR report key: 1222020 · Received October 31, 2008

    Report

    Report Number
    3003910212-2008-00044
    Event Type
    Injury
    Date Received
    October 31, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 31, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NBY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THE PHYSICIAN CALLED GORE AND REPORTED HE HAS A MALE PATIENT THAT UNDERWENT VENTRAL HERNIA REPAIR IN 2007. THE SURGEON CLAIMS THE PATIENT HAS 2 SUTURE ABSCESSES (RIGHT UPPER QUADRANT & LOWER LEFT QUADRANT). THE PHYSICIAN REPORTED THE PATIENT WAS PUT ON ANTIBIOTIC THERAPY FOR A PERIOD OF TIME, AND THE ABSCESS IN THE RIGHT UPPER QUADRANT HEALED. HOWEVER, THE LOWER LEFT QUADRANT ABSCESS IS FLOURISHING. THE PHYSICIAN REPORTED THAT AS HE DEBRIDED THE WOUND, SHORT OF THE FASCIA, HE COULD SEE THE ABSCESS TRACT, AND DRAINED THE ABSCESS. ADDITIONALLY, HE MENTIONED HE HAS NOT CULTURED IN A WHILE. THE PHYSICIAN REPORTED, THE PATIENT IS AT HOME, AND IS BEING TREATED BY HIS WIFE REPACKING THE WOUND. LOT NUMBER INFO IS NOT CURRENTLY AVAILABLE BY BEING REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE-TEX SUTURE CV7 NONE NBY W.L. GORE & ASSOCIATES WLG607

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention