BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX

    MDR report key: 2071746 · Received April 20, 2011

    Report

    Report Number
    1213643-2011-00173
    Event Type
    Injury
    Date Received
    April 20, 2011
    Report Date
    March 29, 2011
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K971745
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INFO PROVIDED BY THE PT AND HOSPITAL, THE PT HAD A COMPOSIX MESH IMPLANTED TO REPAIR A HERNIA ON (B)(6) 2002. NINE YEARS POST IMPLANT, THE PT IS REPORTING A CT SCAN SHOWS A POTENTIAL INFECTION AROUND THE AREA OF THE MESH. THE DIRECTOR OF SURGERY CONTACTED DAVOL TO SEE IF IT WAS A RECALLED PRODUCT, WHICH IT IS NOT. HE SAID THE PT WILL LIKELY UNDERGO EXPLANT SURGERY, BUT THAT PROCEDURE HAS NOT BEEN SCHEDULED. WHILE THERE IS NO INDICATION IN THE INFO PROVIDED THAT SUGGESTS A DEVICE FAILURE, INFECTION IS NOTED AS A POSSIBLE ADVERSE REACTION IN THE PRODUCT'S INSTRUCTIONS FOR USE. THE IFU STATES THAT IF AN INFECTION DEVELOPS, TO TREAT IT AGGRESSIVELY. A REVIEW OF MFG RECORDS WAS PERFORMED, INCLUDING VERIFICATION OF DEVICE STERILITY, AND FOUND NO EVIDENCE OF A MFG-RELATED CAUSE FOR THE ALLEGED EVENT. GIVEN THAT THE ALLEGED REACTION OCCURRED NINE YEARS POST IMPLANT, THE REPORTED EVENT IS ADDRESSED IN THE IFU, AND THERE IS NO EVIDENCE OR ALLEGATION OF DEVICE FAILURE, IT DOES NOT APPEAR THAT THE BARD MESH FAILED. HOWEVER, WITH NO SAMPLE TO EVALUATE AND NO MEDICAL REPORTS TO REVIEW, NO DEFINITIVE CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2002 - PT UNDERWENT OPEN VENTRAL HERNIA REPAIR WITH BARD COMPOSIX MESH. NI/NI/2011 - CT SCAN SHOWS A POSSIBLE INFECTION AROUND THE AREA OF THE MESH IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX FTL DAVOL INC NA 43AMD103

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention