BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD

    MDR report key: 1250487 · Received November 25, 2008

    Report

    Report Number
    MW5009102
    Event Type
    Injury
    Date Received
    November 25, 2008
    Date of Event
    November 19, 2008
    Report Date
    November 25, 2008
    Manufacturer
    DAVOL
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT HAD A KUGEL MESH IMPLANTED IN 2004. THE PT HAS BEEN COMPLAINING OF PROGRESSIVE RECURRING SEVERE RIGHT UPPER QUADRANT PAIN AND UPPER ABDOMINAL PAIN FOR THREE MOS. SHE FEELS PAIN IS SO SEVERE SOMETIMES SHE CANNOT BREATHE, BUT DOES NOT DESCRIBE ACTUAL SHORTNESS OF BREATH OR PLEURITIC PAIN. IN 2008, THE PT HAD THE MESH EXPLANTED. THE PT HAD SIGNIFICANT ADHESIONS BETWEEN THE OMENTUM AND THE MESH WITH THE KUGEL MESH HAVING ADHERED TO THE RIGHT LOWER QUADRANT. IT WAS ACTUALLY TURNED OVER ON ITSELF AND THE MESH WAS INCORPORATED WITH BOTH OMENTUM AND SMALL BOWEL. THE SMALL BOWEL WAS SO ADHERENT TO THE MESH, WHICH REQUIRED SEPARATING THE MESH WITH SCALPEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD KUGEL MESH FTL DAVOL

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Disability