BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVOL

    MDR report key: 2388642 · Received December 18, 2011

    Report

    Report Number
    MW5023541
    Event Type
    Injury
    Date Received
    December 18, 2011
    Report Date
    December 18, 2011
    Manufacturer
    DAVOL
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 1999, I HAD EXCISION OF BILATERAL NODULES FROM SCAR RECONSTRUCTION OF ABDOMINAL WALL WITH MESH. IN THIS OPERATION I HAD TWO PIECES OF DAVOL MESH IMPLANTED -DAVOL 1X4 REF #0112640, LOT #44B1M036 AND DAVOL 2X4 REF #0112650, LOT #43L1D150. I HAVE HAD SEVERE BOWEL PROBLEMS, ABDOMINAL PAIN, BURNING ALONG WITH NUMBING TO CERTAIN PARTS OF MY ABDOMINAL. PAIN WHEN I COUGH, SNEEZE, GET UP FROM LAYING OR SITTING POSITION, WEAR ANY CLOTHES THAT ARE NOT LOOSE AROUND THE AREA OF THE IMPLANTS OF MESH, RECURRENT UTI'S WHICH REQUIRES ME TO BE ON YR ROUND ANTIBIOTICS, LESIONS, THYROID PROBLEMS, AND I HAVE SUSPECTED POSSIBLE FISTULAS IN THE PAST. I AM FATIGUED, IN PAIN, AND EMOTIONALLY EXHAUSTED WITH WHAT I KNOW NOW TO BE ADVERSE REACTIONS FROM THE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAVOL MARLEX MESH FTL DAVOL 44B1M036
    2 DAVOL MARLEX MESH FTL DAVOL 43L1D15

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other