BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH-COMPOSIX KUGEL

    MDR report key: 4202270 · Received October 17, 2014

    Report

    Report Number
    1213643-2014-00385
    Event Type
    Injury
    Date Received
    October 17, 2014
    Report Date
    September 25, 2014
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K061314
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE LIMITED INFO AVAILABLE WE ARE UNABLE TO DETERMINED TO WHAT EXTENT, IF ANY, THE BARD DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S REPORTED RECURRENCE. RECURRENCE AND INFLAMMATION ARE BOTH KNOWN POSSIBLE ADVERSE COMPLICATIONS LISTED IN THE IFU. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFO DAVOL RECEIVED TO DATE. WHEN/IF ADDITIONAL INFO IS PROVIDED AND/OR SURGICAL INTERVENTION TAKES PLACE A SUPPLEMENTAL MDR WILL BE SENT.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL: THE CONTACT REPORTED THAT THE PATIENT WAS IMPLANTED WITH A BARD COMPOSIX KUGEL MESH DURING A HERNIA REPAIR PROCEDURE IN (B)(6) 2008. IT IS REPORTED THAT THE PATIENT IS CURRENTLY EXPERIENCING PAIN IN THE AREA OF THE IMPLANT AND A RECURRENCE HAS BEEN DIAGNOSED. THE PATIENT IS CURRENTLY TAKING ANTIBIOTICS DUE TO C.DIFF AND IS EXPECTED TO HAVE THE MESH REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662741 MESH-COMPOSIX KUGEL FTL FTL DAVOL INC., SUB. C.R. BARD, INC. NA HURB4432

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention