BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KUGEL PATCH

    MDR report key: 1063396 · Received June 19, 2008

    Report

    Report Number
    1213643-2008-00340
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    April 26, 2006
    Report Date
    May 20, 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
    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: IN 2005, A KUGEL MESH PATCH WAS USED TO REPAIR PATIENT'S HERNIA DEFECT. THE PATIENT SUFFERED SEVERE PERSISTENT ABDOMINAL PAIN, WHICH WAS ACCOMPANIED BY ABDOMINAL DISTENTION AND ABDOMINAL TENDERNESS. IN 2006, DUE TO THE PATIENT'S AFORESAID CONDITION, UNDERWENT EXPLORATORY SURGERY. PHYSICIANS DETERMINED THAT THE PREVIOUSLY PLACED KUGEL MESH WAS ROLLED UP INTO THE BOWEL. PHYSICIANS ALSO DISCOVERED SEVERAL DENSE BOWEL TO BOWEL ADHESIONS AND PATCHES OF ROCK HARD ADHESIONS. THE ADHESIONS WERE TAKEN DOWN AND THE FLAPS OF THE PREVIOUSLY PLACED KUGEL MESH WERE SEWN DOWN. PATIENT CONTINUED TO EXPERIENCE INTENSE PAIN IN HER ABDOMINAL REGION, REQUIRING A SECOND SURGICAL PROCEDURE. THE FOLLOWING MONTH, UNDERWENT SURGICAL PROCEDURE AT WHICH TIME THE SURGEON DISCOVERED THE AN INFECTED KUGEL MESH. THE KUGEL MESH WAS EXPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention