BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH

    MDR report key: 1131925 · Received August 22, 2008

    Report

    Report Number
    1213643-2008-00411
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    August 27, 2005
    Report Date
    July 31, 2008
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K971745
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AS NO PROD HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE WILL SUBMIT A F/U REPORT WHEN/IF PROD IS RETURNED FOR EVAL OR ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: IN 2005 - THE PT UNDERWENT AN INCISIONAL HERNIA REPAIR PROCEDURE WITH IMPLANT OF A COMPOSIX DUAL MESH TO THE RIGHT UPPER QUADRANT. AFTER THE IMPLANTATION, PT SUFFERED A BOWEL PERFORATION WHICH CAUSED HER WHITE BLOOD CELL COUNT TO SKYROCKET DANGEROUSLY AND BOWEL CONTENTS AND GAS TO LEAK INTO HER ABDOMINAL CAVITY. PT ALLEGES THE MESH SERRATED HER BOWEL AND/OR DELAMINATED TO CAUSE THE BOWEL PERFORATION AND MESH INFECTION. AT ABOUT APPROX 8 DAYS LATER, THE PT UNDERWENT SURGERY TO EXPLANT THE MESH PATCH WITH A BOWEL RESECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43FOD190

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R