BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KUGEL PATCH

    MDR report key: 1150540 · Received September 3, 2008

    Report

    Report Number
    1213643-2008-00413
    Event Type
    Injury
    Date Received
    September 3, 2008
    Date of Event
    February 27, 2006
    Report Date
    August 4, 2008
    Manufacturer
    DACOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K963141
    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. SEE MEDWATCH 1213643-2008-414 FOR INFORMATION RELATED TO THE OTHER MESH IMPLANTED IN 2004.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: IN 2004 -THE PATIENT UNDERWENT A BILATERAL INGUINAL FEMORAL HERNIA REPAIR PROCEDURE WITH IMPLANT OF TWO KUGEL MESH PATCHES. ONE FROM LOT # 43JND485 AND ONE FROM LOT # 43KND178. PATIENT CONTINUED TO EXPERIENCE ABDOMINAL PAIN AND EXTENSIVE SWELLING THROUGHOUT HER BODY, FACE AND NECK. IN 2006 -THE PATIENT UNDERWENT EXPLORATORY ABDOMINAL SURGERY WITH EXPLANT OF ONE OR BOTH MESH PATCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KUGEL PATCH FTL DACOL INC., SUB. C.R. BARD, INC. NA 43JND485

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention