BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODIFIED KUGEL PATCH

    MDR report key: 1866885 · Received October 7, 2010

    Report

    Report Number
    1213643-2010-00446
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    March 18, 2010
    Report Date
    September 16, 2010
    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

    ADDITIONAL PMA/510(K) #: K021736. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION AND TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. 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.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: ON (B)(6)2009, PATIENT'S LEFT INGUINAL HERNIA WAS REPAIRED WITH A 4-INCH CIRCLE BARD MODIFIED KUGEL HERNIA PATCH. ON (B)(6)2010, PATIENT UNDERWENT SURGERY FOR REPAIR OF A RECURRENT LEFT INGUINAL HERNIA. DURING THE PROCEDURE, THE SURGEON NOTED ADHESIONS OF OMENTUM TO THE MESH, WITH THE MAJORITY OF THE MESH FOLDED OVER. THE SURGEON CONFIRMED THAT THE MESH WAS CURLING BACK UPON ITSELF WITH SEVERAL DIFFERENT FOLDS. HIS SURGEON REMOVED THE REDUNDANT AND FOLDED BACK PIECE OF MESH. PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN AND MENTAL ANGUISH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention