BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 1749251 · Received July 1, 2010

    Report

    Report Number
    1213643-2010-00320
    Event Type
    Injury
    Date Received
    July 1, 2010
    Date of Event
    July 12, 2006
    Report Date
    June 8, 2010
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    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. CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED NOR HAS A SPECIFIC PRODUCT PROBLEM BEEN REPORTED. WHILE RECURRENCE IS A KNOWN ADVERSE EVENT THAT IS LISTED IN THE IFU, NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    INFORMATION REPORTED BY PATIENT TO DAVOL: (B) (6)2004 - PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR WITH MESH IMPLANT. PATIENT REPORTS LLQ (LEFT LOWER QUADRANT) ABDOMINAL PAIN SINCE TIME OF IMPLANT. ON (B) (6)2006 - PATIENT WAS DIAGNOSED WITH A HERNIA RECURRENCE IN THE AREA OF MESH PLACEMENT. THE PATIENT UNDERWENT OPEN RECURRENT HERNIA REPAIR WITH MESH IMPLANT. THE PATIENT REPORTED THE HERNIA RECURRENCE WAS AT THE EDGE OF THE PREVIOUS MESH PLACEMENT. CURRENT/2010 - THE PATIENT REPORTS SHE IS EXPERIENCING WORSENING LLQ PAIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other