BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KUGEL PATCH

    MDR report key: 1903367 · Received November 10, 2010

    Report

    Report Number
    1213643-2010-00481
    Event Type
    Injury
    Date Received
    November 10, 2010
    Report Date
    October 22, 2010
    Manufacturer
    DAVOL 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

    WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION AND TO REQUEST THE 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 REPORTED EVENT AS NO PRODUCT HAS BEEN RETURNED NOR HAS A SPECIFIC PRODUCT PROBLEM BEEN REPORTED. BASED ON THE INFORMATION AVAILABLE, NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2002 - PATIENT UNDERWENT A BILATERAL INGUINAL HERNIA REPAIR SURGERY. PATIENT'S HERNIA WAS REPAIRED WITH TWO SMALL OVAL BARD KUGEL HERNIA PATCHES; PRODUCT CODE NUMBER 0010101. PER THE ATTORNEY IT IS ALLEGED THAT THE PATIENT HAS SUFFERED SYMPTOMS AND INJURIES CONSISTENT WITH THE SYMPTOMS AND INJURIES DESCRIBED BY THE RECALL INFORMATION AND THAT THE 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 KUGEL PATCH FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other