BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 1915655 · Received December 1, 2010

    Report

    Report Number
    1213643-2010-00526
    Event Type
    Injury
    Date Received
    December 1, 2010
    Report Date
    November 5, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL RPTR TO REQUEST ADDITIONAL INFO AND TO REQUEST RETURN OF THE DEVICE FOR EVAL. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. 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.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE ATTORNEY FOR THE PT. ON (B)(6) 2007, PT UNDERWENT SURGERY TO REPAIR A VENTRAL HERNIA. A BARD COMPOSIX KUGEL MESH HERNIA PATCH WAS USED TO REPAIR THE HERNIA. PT SUSTAINED INJURY AND DAMAGES ASSOCIATED WITH USE OF DEFECTIVE PRODUCT, COMPOSIX KUGEL HERNIA PATCH. THE ATTORNEY ALLEGES THAT AS A RESULT OF HAVING THE COMPOSIX KUGEL HERNIA PATCH IMPLANTED, PT SUFFERED AN INFECTION, PERMANENT PERSONAL INJURIES, PAIN AND SUFFERING AND REQUIRED SURGICAL INTERVENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention