BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH

    MDR report key: 1191047 · Received September 24, 2008

    Report

    Report Number
    1213643-2008-00443
    Event Type
    Injury
    Date Received
    September 24, 2008
    Date of Event
    June 11, 2008
    Report Date
    September 4, 2008
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDME
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    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. WE WILL SUBMIT A FOLLOW UP REPORT WHEN/IF PRODUCT IS RETURNED FOR EVAL, OR ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    PT REPORTED VIA MAUDE EVENT REPORT, HE HAD MESH IMPLANTED TO TREAT AN INCISIONAL HERNIA IN 2005. PT REPORTED THAT THE MESH WAS EXPLANTED IN 2008 DUE TO THE MESH BEING BALLED UP INTO A HEAP OF SCAR TISSUE AND THAT HIS FALCIFORM LIGAMENT WAS GOING INTO PART OF THE BALLED UP MESH SO THE LIGAMENT HAD TO BE DIVIDED, AND CUT OUT OF THE MESH. THE PT ALSO REPORTED THE DEFECT SIZE INSIDE OF HIS ABDOMEN TO BE 14 CM IN LENGTH AND 6 CM IN WIDTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH FTL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43COD412

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other