BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 1903365 · Received November 10, 2010

    Report

    Report Number
    1213643-2010-00483
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    May 13, 2009
    Report Date
    October 22, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION AND TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. BASED ON THE INFORMATION AVAILABLE, NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE ATTORNEY FOR THE PATIENT: ON (B)(6) 2007 - PATIENT UNDERWENT A COMBINED PARASTOMAL AND VENTRAL HERNIA REPAIR, AT WHICH TIME A SMALL OVAL COMPOSIX KUGEL MESH, PRODUCT CODE 0010201 WAS IMPLANTED. ON (B)(6) 2009 - PATIENT WAS TAKEN TO THE OPERATING ROOM FOR REPAIR AND RELOCATION OF HER RECURRENT PARASTOMAL HERNIA. DURING SURGERY, THE SURGEON NOTED ADHESIONS OF THE SMALL BOWEL TO THE MESH, AND REMOVED A PIECE OF "TURN DOWN PTFE." THE ATTORNEY ALLEGES THAT 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 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R