BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KUGEL PATCH

    MDR report key: 2821310 · Received October 12, 2012

    Report

    Report Number
    1213643-2012-00692
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    March 26, 2004
    Report Date
    May 12, 2008
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K963141
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION RELATED TO THE RECALLED COMPOSIX KUGEL MESH IMPLANTED ON (B)(6) 2005, WILL BE REPORTED IN ACCORDANCE WITH RAE 2008-004. AS REPORTED, THE PATIENT EXPERIENCE VOMITING WHICH COMPROMISED THE REPAIR AND NECESSITATED THE NEED FOR SURGICAL INTERVENTION. THE ISSUE IS NOT DEVICE RELATED. SEE MDR 1213643-2012-00693 FOR INFORMATION RELATED TO THE FLAT MESH IMPLANTED ON (B)(6) 2004.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON THE MEDICAL RECORDS PROVIDED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2004 - PATIENT UNDERWENT VENTRAL HERNIA REPAIR WITH IMPLANT OF A KUGEL PATCH. THE HERNIA WAS INCARCERATED AND INVOLVED A SLIDING COMPONENT WITH THE BLADDER. THAT EVENING, POST-OP, "SHE VOMITED AND FELT SOMETHING PULL OR SNAP IN HER ABDOMEN". ON (B)(6) 2004 - PATIENT UNDERWENT EXPLORATORY PROCEDURE FOR PAIN AND 'FULLNESS' IN HER WOUND. THE KUGEL PATCH HAD COME FREE. THREE STITCHES WERE NOT INTACT, AND TWO SUTURES, WHICH WERE STILL ATTACHED TO THE FASCIA WITH KNOTS INTACT, HAD TORN THROUGH THE MESH. THE HERNIA HAD REOCCURRED BETWEEN THE FASCIA AND THE KUGEL PATCH. KUGEL PATCH WAS EXPLANTED AND REPLACED WITH IMPLANT OF A FLAT MESH, WHICH WAS CUT TO SIZE. ON (B)(6) 2005 - PATIENT UNDERWENT REPAIR OF HERNIA RECURRENCE. THE FLAT MESH WAS EXPLANTED AND A COMPOSIX KUGEL MESH WAS IMPLANTED. LYSIS OF ADHESIONS WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KUGEL PATCH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 091099

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention