BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOSIX MESH E/X

    MDR report key: 1386931 · Received May 15, 2009

    Report

    Report Number
    1213643-2009-00234
    Event Type
    Injury
    Date Received
    May 15, 2009
    Date of Event
    April 25, 2006
    Report Date
    April 22, 2009
    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

    REPORT DOES NOT INDICATE AND SPECIFIC PRODUCT PROBLEM. IN ADDITION, IT IS UNKNOWN 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 EVALUATION OR ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: IN 2005 -- THE PATIENT UNDERWENT A COMPLEX VENTRAL HERNIA REPAIR PROCEDURE WITH PLACEMENT OF A COMPOSIX E/X MESH PATCH. IN 2006 -- AFTER THE PRODUCT FAILED AND CAUSED AN ABDOMINAL WALL ABSCESS, THE PATIENT UNDERWENT AN EXPLORATORY SURGERY TO REMOVE THE MESH PATCH. THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN AND MENTAL ANGUISH.

    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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention