BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOSIX MESH E/X

    MDR report key: 1150469 · Received September 5, 2008

    Report

    Report Number
    1213643-2008-00422
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    October 10, 2007
    Report Date
    August 6, 2008
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K002684
    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 HAE 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

    ATTORNEY REPORTED: 2007 - THE PT UNDERWENT A VENTRAL HERNIA REPAIR PROCEDURE WITH IMPLANT OF A COMPOSIX E/X MESH. AFTER IMPLANTATION, PT SUFFERED SEVERE PAIN AT THE MESH SITE AND THE MESH FORMED A HARDENED MASS. "ON INFO AND BELIEF, THE MESH CONCRETIZED AND/OR DELAMINATED, CAUSING [PT'S] SEVERE PAIN." AT APPROXIMATELY 8 MONTHS LATER - PT'S DEFECTIVE MESH REQUIRED EXPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPOSIX MESH E/X FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43EOD376

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention