BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPOSIX MESH E/X

    MDR report key: 1190049 · Received October 3, 2008

    Report

    Report Number
    1213643-2008-00447
    Event Type
    Injury
    Date Received
    October 3, 2008
    Date of Event
    September 6, 2006
    Report Date
    September 5, 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 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: 2006 - PATIENT UNDERWENT SURGERY TO REPAIR AN INCISIONAL HERNIA. A BARD COMPOSIX EX MESH HERNIA PATCH WAS USED TO REPAIR THE HERNIA. AS A RESULT OF USING THE MESH, THE PATIENT WAS CAUSED TO SUFFER, AMONG OTHER INJURIES, SEVERE INFECTION, BOWEL HERNIATION, AND WAS HOSPITALIZED AND CAUSED TO SUSTAIN SEVERE AND PERMANENT PERSONAL INJURIES, PAIN, SUFFERING, AND EMOTIONAL DISTRESS. THE BOWEL HERNIATION AND SEVERE INFECTION SUSTAINED BY THE PATIENT WAS DUE TO THE BARD COMPOSIX MESH HERNIA PATCH.

    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 Hospitalization| S