BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 1945610 · Received December 9, 2010

    Report

    Report Number
    1213643-2010-00538
    Event Type
    Injury
    Date Received
    December 9, 2010
    Report Date
    November 10, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K061314
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, THE PT HAS BEEN DIAGNOSED WITH A RECURRENCE, WHICH IS KNOWN POSSIBLE ADVERSE EVENT LISTED IN THE IFU. HOWEVER, IT SHOULD ALSO BE NOTED THAT THE LOCATION OF THE RECURRENCE IS NOT AT THE ORIGINAL SITE OF THE IMPLANTED MESH. THERE WAS NO SPECIFIC PRODUCT PROBLEM NOTED, THEREFORE, BASED ON THE CURRENTLY AVAILABLE INFO, THERE IS NO INDICATION THAT A FAILURE IN THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION, INCLUSIVE OF MEDICAL RECORDS. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFORMATION DAVOL HAS REC'D TO DATE.

    Description of Event or Problem · 1

    INFORMATION REPORTED BY PT: ON (B)(6) 2008 - THE PT UNDERWENT OPEN MESH IMPLANT FOR INCISIONAL HERNIA REPAIR. THE AREA OF THE REPAIR WAS REPORTED BY THE PT TO BE BELOW THE LEVEL OF HER UMBILICUS AND ON THE LEFT SIDE. THREE MONTHS POST IMPLANT, THE PT REPORTED, SHE BEGAN TO DEVELOP CONSTANT LEFT SIDED ABDOMINAL PAIN, A TEARING FEELING AND SWELLING IN THE AREA OF THE MESH IMPLANT. THE PT UNDERWENT INVASIVE PAIN CLINIC TREATMENTS WITH NO RELIEF OF THE REPORTED PAIN SYMPTOMS. IN (B)(6) 2010, THE PT UNDERWENT 2 ABDOMINAL CT SCANS. THE CT REVEALED A NEW HERNIA IN ANOTHER LOCATION (ABOVE THE UMBILICUS). THE PT IS MEETING WITH HER SURGEON IN THE NEAR FUTURE AND MAY UNDERGO A POSSIBLE EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA HURE1004

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other PAIN THERAPY