BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KUGEL PATCH

    MDR report key: 2032716 · Received March 17, 2011

    Report

    Report Number
    1213643-2011-00083
    Event Type
    Injury
    Date Received
    March 17, 2011
    Report Date
    February 25, 2011
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADD'L INFO AND TO REQUEST RETURN OF THE DEVICE FOR EVAL. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: PT SUSTAINED INJURY ASSOCIATED WITH DEFECTIVE PRODUCT, THE BARD KUGEL HERNIA PATCH. AS A RESULT OF HAVING THE PATCH IMPLANTED IN PT, PT SUFFERED DISABLING PAIN AND REQUIRED SURGICAL INTERVENTION. PT SUFFERED AND WILL CONTINUE TO SUFFER INJURY, DISABILITY.

    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| S