BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVOL BARD

    MDR report key: 2539302 · Received April 12, 2012

    Report

    Report Number
    MW5025049
    Event Type
    Injury
    Date Received
    April 12, 2012
    Date of Event
    July 23, 2011
    Report Date
    April 12, 2012
    Manufacturer
    DAVOL, A BARD COMPANY
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN (B)(6) 2004, I DEVELOPED TWO PROTRUDING LUMPS FROM MY ABDOMEN, INITIALLY ONE ABOVE MY NAVEL AND THEN ANOTHER FROM WITHIN MY NAVEL. I WAS REFERRED FOR A SURGICAL CONSULT FOR DIAGNOSIS OF HERNIA BY MY PRIMARY MEDICAL DOCTOR. ON (B)(6) 2004, I HAD OUTPATIENT SURGERY FOR A DOUBLE HERNIA REPAIR, EPIGASTRIC AND UMBILICAL HERNIORRAPHIES WERE PERFORMED. APPROX 2008, I DEVELOPED OCCASIONAL EPISODES OF BLOATING, ABDOMINAL PAIN, NAUSEA AND VOMITING. EPISODES OF NAUSEA AND VOMITING BECAME INCREASINGLY MORE FREQUENT IN 2010 AND 2011. IN THE EARLY MORNING HOURS OF (B)(6) 2011, I DEVELOPED INTRACTABLE NAUSEA AND VOMITING WITH INCREASINGLY SEVERE LIFE-THREATENING ABDOMINAL PAIN WHICH REQUIRED MY TRANSPORT VIA AMBULANCE TO (B)(6). I WAS ADMITTED FOR EMERGENCY SMALL BOWEL RESECTION DUE TO AN INTESTINAL OBSTRUCTION. I WAS TOLD THAT THE IMPLANTED MESH FROM MY PREVIOUS HERNIA SURGERY IN 2004 HAD ADHERED TO MY SMALL INTESTINE LEADING TO AN OBSTRUCTION AND NECROSIS OF A SECTION OF SMALL BOWEL. HOSPITALIZED FOR 8 DAYS AND WAS READMITTED WITHIN 72 HOURS FOR ANOTHER 8 DAYS DUE TO A BLOOD CLOT IN MY RIGHT THIGH. I BEGAN TO AGAIN HAVE EPISODES OF BLOATING, NAUSEA, VOMITING, AND SEVERE ABDOMINAL PAIN IN (B)(6) 2011. I WAS EVALUATED IN (B)(6) FOUR TIMES FOR EXTREMELY PAINFUL INTESTINAL OBSTRUCTIONS OVER THE COURSE OF 2 MONTHS BEFORE BEING ADMITTED AGAIN ON (B)(6) 2011. I HAD AN OPEN EXPLORATORY LAPAROTOMY BY MY SURGEON WHERE REMAINING MESH AND ADHESIONS WERE CLEANED OUT. PLACEMENT OF A VENOUS FILTER WAS NECESSARY PRIOR TO THE SECOND SURGERY DUE TO THE BLOOD CLOT IN MY THIGH. I WAS HOSPITALIZED FOR 11 DAYS. ON (B)(6) 2012, I HAD ANOTHER EXTREMELY PAINFUL EPISODE OF BOWEL OBSTRUCTION WHICH REQUIRED TREATMENT AT (B)(6). EVERY DAY I HAVE TO LIVE WITH BLOATING, AND EXTREME INTESTINAL DISCOMFORT WHICH HAS EFFECTED THE QUALITY OF MY LIFE. OBSTRUCTIONS AND ADHESIONS CONTINUE TO BE A HUGE PROBLEM EVEN WHILE MAINTAINING A STRICT DIET AND HYDRATION. THE MESH PRODUCT USED IN MY DOUBLE HERNIA OPERATION IN 2004 DAVOL BARD PERFIX PLUG MEDIUM AND LARGE, MONOFILAMENT KNITTED POLYPROPYLENE WAS THE CAUSE OF THE DOWNFALL OF MY HEALTH. THE REFERENCE AND LOT NUMBER ARE AS FOLLOWS: MEDIUM PLUG (B)(4), LOT 43BND104, LARGE PLUG (B)(4), LOT 43AND058. PERMANENT DAMAGE HAS OCCURRED TO MY SMALL BOWEL BECAUSE OF THE MESH USED IN 2004 TO REPAIR MY DOUBLE HERNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAVOL BARD PERFIX PLUG, MONOFILAMENT KNITTED POLYPROPYLESE MESH FTL DAVOL, A BARD COMPANY 43BND104
    2 DAVOL BARD PERFIX PLUG, MONOFILAMENT KNITTED POLYPROPYLENE MESH FTL DAVOL, A BARD COMPANY 43AND058

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| O| R| S