BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA PLUS POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM

    MDR report key: 1078250 · Received July 17, 2008

    Report

    Report Number
    MW5007688
    Event Type
    Injury
    Date Received
    July 17, 2008
    Date of Event
    December 3, 2007
    Report Date
    July 17, 2008
    Manufacturer
    BARD UROGICAL, C.R. BARD, INC
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I REC'D AN AVAULTA PLUS POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM TO CORRECT A RECTOCELE IN LATE 2007. TO DATE, IN 2008, THE TWO BUTTOCKS INCISIONS ARE DRAINING WHICH THEY HAVE DONE CONTINUOUSLY SINCE FIVE MONTHS EARLIER. ACCORDING TO MY PHYSICIAN, THE ADDITION OF THE BOVINE PRODUCT TO THE MESH IS THE CAUSE OF THIS. ON THE FOLLOWING MONTH, I EMAILED THE BARD HELPLINE TO TELL THEM OF THE PROBLEM AND TO ASK THE CAUSE AND REMEDY. ON 03/11/08 MEDICAL SERVICES EMAILED ME TO PLEASE CALL THEIR OFFICE WHICH I DID. IT WAS A VERY UNSATISFACTORY CONTACT. WITH NO INFO FORTHCOMING, AND NO RESOLUTION OF THIS PROBLEM, I FINALLY WROTE C. R. BARD, INC. ON 06/25/08. ON 07/14/08 I RECEIVED A LETTER FROM QUALITY ASSURANCE & REGULATORY AFFAIRS, TO WHOM MY LETTER TO CO HAD BEEN REFERRED, IN WHICH HE WROTE: "AS A MEDICAL DEVICE MANUFACTURER, BARD MUST PROVIDE CERTAIN INFO RELATED TO THIS EVENT TO THE U.S. FOOD & DRUG. ADMN. IN ACCORDANCE WITH FDA REPORTING REQUIREMENTS." ENCLOSED WAS A MEDICAL RELEASE FORM FOR ME TO FILL, SIGN, AND RETURN TO THEM SO THEY CAN ACCESS MY RECORDS. THEY WERE NOT INTERESTED IN REPORTING TO YOU WHEN I CONTACTED THEM IN EARLY MARCH, AND THEY DID NOT ASK OR TELL ME THE TIME THAT THEY NEEDED TO REPORT THIS AND NEEDED ME TO SIGN RELEASES SO THAT THEY WOULD BE ABLE TO DO SO. DATES OF USE: 2007 - 2008. DIAGNOSIS OR REASON FOR USE: RECTOCELE REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVAULTA PLUS POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM MESH PATCH TO REPAIR RECTOCELE FTL BARD UROGICAL, C.R. BARD, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other