BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH-COMPOSIX KUGEL

    MDR report key: 4202294 · Received October 17, 2014

    Report

    Report Number
    1213643-2014-00381
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    May 18, 2012
    Report Date
    September 30, 2014
    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
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO PROVIDED WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY, THE BARD DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED. A REVIEW OF THE MANUFACTURING RECORDS WAS CONDUCTED AND FOUND NO ANOMALIES. RECURRENCE AND ADHESIONS ARE BOTH KNOWN POSSIBLE COMPLICATIONS LISTED IN THE IFU. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. IF ADDITIONAL IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THE PATIENT: THE PATIENT ALLEGES THAT SHE UNDERWENT A SURGICAL PROCEDURE IN 2007 OR 2008, WITH THE IMPLANT OF A BARD/DAVOL COMPOSIX KUGEL MESH, FOR REPAIR OF A VENTRAL HERNIA. THE PATIENT REPORTS THAT SHE DEVELOPED ABDOMINAL PAIN, CAUSING HER TO VISIT HER IMPLANTING SURGEON WHO PREFORMED A CT SCAN REVEALING A POSSIBLE RECURRENCE, AT THE SAME LOCATION OF THE MESH THAT WAS PLACED PREVIOUSLY. THE PATIENT REPORTS THAT ON (B)(6) 2012 SHE UNDERWENT A REPAIR PROCEDURE AND DURING THIS PROCEDURE, THE MESH WAS FOUND TO BE ADHERED TO THE BOWEL. A PORTION OF THE BOWEL WAS RESECTED AND THE MESH WAS REMOVED. THE HERNIA AS WELL AS A SECOND HERNIA WAS REPAIRED PRIMARILY. THE PATIENT REPORTS THAT SHE HAD NOT HAD ANY SURGERIES OR INJURIES BETWEEN THE TIME OF IMPLANT AND EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662734 MESH-COMPOSIX KUGEL FTL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43FQD182

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention