BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 3070731 · Received April 15, 2013

    Report

    Report Number
    1213643-2013-00152
    Event Type
    Injury
    Date Received
    April 15, 2013
    Report Date
    March 29, 2013
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K061314
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE ATTORNEY REPORT ALLEGES THAT THE PT WAS IMPLANTED WITH COMPOSIX KUGEL MESH AND TWO YEARS LATER WAS IMPLANTED WITH A VENTRALEX PATCH AND COMPOSIX KUGEL MESH. ALSO ALLEGED IS THAT ON AN UNSPECIFIED DATE THE PT UNDERWENT SURGERY TO REMOVE PORTIONS OF THE IMPLANTS. NO SPECIFIC DEVICE FAILURE HAS BEEN ALLEGED AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED. IT HAS BEEN ALLEGED THAT THE PT WAS TREATED FOR ADHESIONS AND INFECTION, BOTH OF WHICH ARE KNOWN POSSIBLE ADVERSE EVENTS LISTED IN THE IFU. THE WARNING SECTION OF THE IFU STATES: "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. THE PROTHESIS MAY NOT HAVE TO BE MOVED. AN UNRESOLVED INFECTION, HOWEVER, MAY REQUIRE REMOVAL OF THE PROSTHESIS." A LOT NUMBER WAS NOT INCLUDED IN THE ATTORNEY'S REPORT; THEREFORE, A REVIEW OF THE MFG RECORDS COULD NOT BE CONDUCTED. ADDITIONALLY, NO PRODUCT WAS RETURNED FOR EVAL. WITH THE CURRENTLY AVAILABLE INFO, NO CONCLUSION CAN BE DRAWN. IF ADD'L EVENT AND/OR EVAL INFO IS OBTAINED, A F/U MDR WILL BE SUBMITTED. SEE MDR 1213643-2013-00153, FOR INFO RELATED TO THE COMPOSIX KUGEL MESH THAT WAS ALLEGED TO HAVE BEEN IMPLANTED ON (B)(6) 2010. SEE MDR 1213643-2013-00154, FOR INFO RELATED TO THE VENTRALEX PATCH THAT WAS ALLEGED TO HAVE BEEN IMPLANTED ON (B)(6) 2010.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THE PT'S ATTORNEY. ON (B)(6) 2008, PT WAS IMPLANTED WITH COMPOSIX KUGEL MESH. ON (B)(6) 2010, PT WAS IMPLANTED WITH A VENTRALEX PATCH AND COMPOSIX KUGEL MESH. PT HAD SURGERY TO ATTEMPT TO REMOVE PORTIONS OF THE VENTRALEX PATCH AND COMPOSIX KUGEL MESH. THE ATTORNEY'S REPORT ALLEGES DISABILITY, INFECTION, PAIN, ADHESION, ADDITIONAL SURGERY, DEFECTIVE MESH, EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160881 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability