BEUDAMED
    FDA Adverse Event Other Summary report: N

    KUGEL / BARD

    MDR report key: 852056 · Received May 11, 2007

    Report

    Report Number
    MW1042888
    Event Type
    Other
    Date Received
    May 11, 2007
    Date of Event
    October 31, 2005
    Report Date
    May 11, 2007
    Manufacturer
    DAVOL INDUSTRIES
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    KUGEL/BARD MESH -2X3- LOT #0112660 AND MESH -3X5- LOT #43APD018 INSERTED TO REPAIR INCISIONAL HERNIA IN 2005. PATIENT BEGUN FEELING PAIN IN LOWER RIGHT ABDOMEN WITHIN A MONTH AFTER SURGERY. SURGEON ATTEMPTED TO ALLEVIATE PAIN BY REMOVING SUTURES. PAIN STILL PERSISTED. PATIENT HAS BEEN EXPERIENCING SEVERE ABDOMINAL PAIN ON REPAIR SITE FOR THE PAST 7 MONTHS WITH NO MEDICAL REASON FOR IT. PATIENT HAS HAD MRI, CT SCAN, ULTRASOUNDS, X-RAYS, GALLIUM SCAN, MECKEL SCAN AND BARIUM ENEMAS. PATIENT CANNOT FUNCTION WITHOUT PAIN KILLERS. PAIN IS INTERRUPTING SLEEP AND DAILY LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KUGEL / BARD HERNIA MESH PATCH 2X3 FTL DAVOL INDUSTRIES * 0112660
    2 KUGEL / BARD HERNIA MESH PATCH 3X5 FTL DAVOL INDUSTRIES * 43APD018

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other