BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 1874179 · Received October 15, 2010

    Report

    Report Number
    1213643-2010-00452
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    August 12, 2009
    Report Date
    September 24, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFO AND TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. THIS MDR INCLUDES ALL, PT'S EVENT AND DEVICE'S 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

    ATTORNEY REPORTED: ON (B)(6)2007 - PT UNDERWENT VENTRAL HERNIA REPAIR SURGERY. PT'S HERNIA WAS REPAIRED WITH A SMALL OVAL BARD COMPOSIX KUGEL MESH. ON (B)(6)2009 - PT PRESENTED TO HOSPITAL SUFFERING FROM AN ENTEROCUTANEOUS FISTULA AND INFECTED MESH. PT IMMEDIATELY UNDERWENT SURGICAL REPAIR. DURING THE PROCEDURE, THE SURGEON NOTED THAT "THE SMALL BOWEL SEGMENT EXTENDED UP TO THE MESH AND WAS ADHERENT TO THE MESH." SURGEON DISSECTED THE SMALL BOWEL FROM THE MESH AND FOUND A SMALL OPENING IN THE SMALL BOWEL. SURGEON REPAIRED THE OPENING IN THE SMALL BOWEL BY PERFORMING A BOWEL RESECTION AND END-TO-END ANASTOMOSIS. ONCE THE SMALL BOWEL RESECTION HAD BEEN COMPLETED, THE OLD INFECTED MESH WAS EXCISED FROM THE ABDOMINAL WALL AND THE DEFECT WAS REPAIRED WITH AN ALLODERM MESH. ON (B)(6)2009 - PT WAS DISCHARGED. BECAUSE OF THE DEFECTIVE COMPOSIX KUGEL PATCH, AND THE MULTIPLE MEDICAL VISITS AND SURGERIES NECESSITATED, PT 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 43DQD243

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R