BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KUGEL PATCH

    MDR report key: 3170585 · Received June 5, 2013

    Report

    Report Number
    1213643-2013-00249
    Event Type
    Injury
    Date Received
    June 5, 2013
    Report Date
    May 21, 2013
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K963141
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION AND IF AVAILABLE, TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. IF ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS PROVIDED TO DAVOL BY THE PATIENT'S ATTORNEY: IT WAS ALLEGED THAT ON (B)(6) 2005, THE PATIENT WAS IMPLANTED WITH A KUGEL HERNIA PATCH TO REPAIR A HERNIA. THE ATTORNEY ALLEGES THAT THE PATCH WAS DEFECTIVE. PATIENT HAS SUSTAINED PAIN AND SUFFERING, LOSS OF PHYSICAL FUNCTION, PERMANENT AND TEMPORARY PHYSICAL INJURIES. ON UNSPECIFIED DATES THE PATIENT HAS UNDERGONE MEDICAL TREATMENT AND WILL LIKELY UNDERGO FURTHER MEDICAL TREATMENT AND PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249565 KUGEL PATCH FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Disability