BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 1150536 · Received September 3, 2008

    Report

    Report Number
    1213643-2008-00417
    Event Type
    Injury
    Date Received
    September 3, 2008
    Date of Event
    March 6, 2008
    Report Date
    August 4, 2008
    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

    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: 2004-THE PATIENT UNDERWENT AN INCISIONAL HERNIA REPAIR PROCEDURE WITH IMPLANT OF A COMPOSIX KUGEL HERNIA PATCH. PATIENT CONTINUED TO HAVE ABDOMINAL PAIN AND DISCOMFORT. IN 2008 - PATIENT WAS NOTED TO HAVE A MASS AT THE SITE OF THE PREVIOUS HERNIA MESH REPAIR. IN THE SAME MONTH - THE PATIENT UNDERWENT SURGERY REPAIR FOR SUBFASCIAL ABSCESS, BOWEL PERFORATION, INFECTED MESH, REMOVAL OF PREVIOUS PLACED MESH, REPAIR OF SMALL BOWEL PERFORATION, DRAINAGE AND DEBRIDEMENT OF SUBFASCIAL ABSCESS, LYSES OF ADHESIONS, AND REPAIR OF ABDOMINAL WALL DEFECT WITH PRIMARY CLOSURE. THE SURGEON NOTES IN THE OPERATIVE REPORTS THAT THE SUBFASCIAL ABSCESS WAS AT THE EDGE OF THE PREVIOUSLY PLACED MESH AND IMMEDIATELY ADJACENT TO THE MESH WAS A HOLE IN THE SMALL BOWEL. ALSO NOTES IN THE OPERATIVE REPORT THAT "THE AREA OF PERFORATION OF THE BOWEL WAS NOTED TO BE ADJACENT TO THE MESH IN THE AREA WHERE THE BARD KUGEL COMPOSIX MESH OUTER PLASTIC RING APPEARED TO HAVE BUCKLED CREATING A PROMINENCE OF THE PLASTIC RING PROTRUDING TOWARDS THE ABDOMINAL CAVITY"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43FOD280

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R