BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTRALEX MESH

    MDR report key: 1519868 · Received October 30, 2009

    Report

    Report Number
    1213643-2009-00461
    Event Type
    Injury
    Date Received
    October 30, 2009
    Date of Event
    October 15, 2007
    Report Date
    October 6, 2009
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K021736
    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 PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. BASED ON THE AVAILABLE INFO, WE ARE UNABLE TO DISCERN WHICH OF OR HOW MANY OF THE THREE VENTRALEX MESH PATCHES IMPLANTED IN 2004 WAS FOUND TO BE RIGID AND ADHERENT TO THE SMALL BOWEL. THEREFORE, WE ARE REPORTING EACH DEVICE. SEE MDR 1213643-2009-00462 AND MDR 1213643-2009-00463 FOR INFO RELATED TO THE OTHER TWO VENTRALEX MESH PATCHES IMPLANTED IN 2004. INFO RELATED TO THE COMPOSIX KUGEL MESH IMPLANTED IN 2002 WILL BE REPORTED. THERE IS NO INDICATION THAT THE COMPOSIX KUGEL IMPLANTED IN 2004 CAUSED OR CONTRIBUTED TO THE BOWEL OBSTRUCTION, HOWEVER, BASED ON THE AVAILABLE INFORMATION, WE ARE UNABLE TO DEFINITIVELY DISCERN IF THE COMPOSIX KUGEL IMPLANTED CAUSED OR CONTRIBUTED TO THE PT'S SUBSEQUENT PAIN AND MENTAL ANGUISH. THEREFORE, INFO RELATED TO THE COMPOSIX KUGEL MESH IMPLANTED ON THE SAME DAY, WILL BE REPORTED.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: IN 2002 - THE PT HAD A LARGE OVAL COMPOSIX KUGEL MESH, IMPLANTED TO REPAIR A VENTRAL HERNIA DEFECT. IN 2004 - THE PT UNDERWENT SURGERY FOR A RECURRENT LARGE VENTRAL HERNIA. THE SURGEON NOTED THAT THE PREVIOUSLY PLACED MESH HAD FAILED. UPON INFO AND BELIEF, AT THIS TIME A BARD COMPOSIX KUGEL HERNIA PATCH, TWO BARD VENTRALEX HERNIA PATCHES PRODUCT CODE 0010301 LOT 43HOD342 AND ONE BARD VENTRALEX HERNIA PATCH PRODUCT CODE 0010301 LOT 43HOD340 WERE PLACED. IN 2007 - THE PT PRESENTED TO HIS PHYSICIAN WITH A SMALL BOWEL OBSTRUCTION. UPON INFO AND BELIEF, PATIENT'S SURGEON FOUND THAT THE VENTRALEX MESH WAS RIGID AND ADHERENT TO THE SMALL BOWEL AND PERFORMED ADHESIOLYSIS TO CORRECT THE SMALL BOWEL OBSTRUCTION. PLAINTIFF HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN AND MENTAL ANGUISH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTRALEX MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43HOD342

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention