BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVOL

    MDR report key: 1212045 · Received October 26, 2008

    Report

    Report Number
    MW5008776
    Event Type
    Injury
    Date Received
    October 26, 2008
    Date of Event
    September 16, 2005
    Report Date
    October 26, 2008
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN1988, I WAS IMPLANTED WITH DAVOL MARLEX MESH. IN 2005, I WENT TO THE SAME SURGEON WITH CHRONIC PAIN ISSUES. HE DID A ADHESION REPAIR. SINCE THAT TIME I HAVE HAD BURNING, INTENSE PULLING, ABDOMINAL SWELLING AND DISTORTION. PRIOR TO THIS SURGERY, MY INCISION AREA WAS TENDER TO THE TOUCH. NOW, I ALSO HAVE A FIRM SPOT NEAR MY BELLY BUTTON AREA. I SEE A SURGEON ON THE 3RD TO SEE WHAT THIS COULD BE. THE SURGEON THAT THE ADHESION REPAIR TOLD ME WEEKS AFTER THAT SURGERY THAT THERE WAS NOTHING ELSE HE COULD DO FOR ME. I WAS CALLING WEEKLY BECAUSE OF PAIN AND PULLING. I NOW HAVE IBS TYPE SYMPTOMS, EXTREMELY PAINFUL. I WILL FIND OUT IF THIS IS THE MESH. I DON'T BELIEVE THAT ANY OF THE MESH USED BACK THEN ARE WHAT THEY WERE BUILT UP TO BE. I WAS NEVER TOLD OF ANY SIDE AFFECTS THAT COULD OCCUR. NO LITERATURE WAS GIVEN. DATES OF USE: 1988 - 2008. DIAGNOSIS OR REASON FOR USE: INCISIONAL HERNIAS FROM HAVING GALLBLADDER REMOVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Disability