BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KUGEL PATCH

    MDR report key: 1883843 · Received October 22, 2010

    Report

    Report Number
    1213643-2010-00459
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    March 31, 2009
    Report Date
    September 29, 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
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFO AND TO REQUEST RETURN OF THE DEVICE FOR EVAL. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. CURRENTLY, IT IS UNK 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: (B)(6) 2009 - PT UNDERWENT LEFT SPIGELIAN HERNIA REPAIR. PT'S HERNIA WAS REPAIRED WITH A MEDIUM OVAL KUGEL PATCH. IN OR AROUND (B)(6) OF 2009, PT PRESENTED WITH SEVERE PERSISTENT ABDOMINAL PAIN, WHICH WAS ACCOMPANIED BY ABDOMINAL DISTENTION, AND ABDOMINAL TENDERNESS. ON (B)(6) 2009 - THE KUGEL PATCH WAS REMOVED FROM PT. PHYSICIANS DISCOVERED THAT THE PREVIOUSLY PLACED KUGEL PATCH HAD BALLED UP REQUIRING REMOVAL OF THE MESH. THIS CONTRIBUTED TO PT'S ABOVE-DESCRIBED PAIN. PT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN AND MENTAL ANGUISH. THE DATES REPORTED ARE AS REPORTED BY THE ATTORNEY.

    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