BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KUGEL PATCH

    MDR report key: 2232576 · Received August 24, 2011

    Report

    Report Number
    1213643-2011-00396
    Event Type
    Injury
    Date Received
    August 24, 2011
    Report Date
    August 3, 2011
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K963141
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. BASED ON THE ATTORNEY REPORT THE PATIENT UNDERWENT HERNIA REPAIR WITH KUGEL PATCH IN (B)(6) 2005. FOLLOWING THE PROCEDURE, THE PATIENT HAD NUMEROUS COMPLICATIONS AND REQUIRED MULTIPLE PHYSICIAN VISITS. SUBSEQUENTLY, THE PATIENT CONTINUED TO HAVE PROBLEMS ASSOCIATED AT THE SITE OF THE HERNIA REPAIR. ACCORDING TO THE LAWYER THE PATIENT NEEDS SURGERY TO REMOVE THE MESH, HER SURGEON, HAS DOCUMENTED THAT SHE IS NOT A CANDIDATE FOR SURGERY DUE TO HER OTHER SERIOUS HEALTH CONDITIONS. SHE CONTINUES TO BE MONITORED. BASED ON THE INFORMATION PROVIDED IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE ALLEGED EVENT. THE REPORT DOES NOT IDENTIFY A SPECIFIC DEVICE PROBLEM AND NO PRODUCT WAS RETURNED FOR EVALUATION. ADDITIONALLY, MEDICAL RECORDS HAVE NOT BEEN PROVIDED AT THIS TIME. WITH THE CURRENTLY AVAILABLE INFORMATION, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE ATTORNEY FOR THE PATIENT: ON (B)(6) 2005 - THE PATIENT UNDERWENT SURGERY. A REPAIR OF A HERNIA WAS PERFORMED USING KUGEL MESH. THE ATTORNEY ALLEGES THE KUGEL PATCH USED IN THE PATIENT'S HERNIA REPAIR SURGERY FAILED, RESULTING IN THE SERIOUS INJURIES TO THE PATIENT. THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN, IMPAIRMENT, DISABILITY, AND DISFIGUREMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KUGEL PATCH FTL DAVOL INC NA 43GOD183

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability