BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 2062375 · Received April 5, 2011

    Report

    Report Number
    1213643-2011-00137
    Event Type
    Injury
    Date Received
    April 5, 2011
    Report Date
    March 17, 2011
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON PATIENT'S REPORT DURING TELEPHONE CONVERSATIONS, THE PATIENT UNDERWENT A REPAIR FOR A MIDLINE HERNIA USING A COMPOSIX KUGEL MESH. PATIENT CLAIMS TO HAVE SUFFERED ABDOMINAL PAIN SINCE THEN. TEN YEARS AFTER THE IMPLANT, SHE SAYS SHE HAD A CONSULTATION WITH A SURGEON WHO TOLD HER EXPLANT OF THE MESH WOULD BE "LIFE THREATENING." MULTIPLE ATTEMPTS TO OBTAIN MEDICAL RECORDS RELATED TO THE HERNIA REPAIR FROM THE PATIENT HAVE BEEN UNSUCCESSFUL. FURTHERMORE, WITH NO SPECIFIC DEVICE FAILURE BEING ALLEGED OR IDENTIFIED, THERE IS NOT ENOUGH INFORMATION AVAILABLE TO REACH A CONCLUSION ABOUT THE DEVICE IN QUESTION. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE.

    Description of Event or Problem · 1

    BASED ON PATIENT'S REPORT VIA TELEPHONE CONVERSATION: IN 2000 - PATIENT STATES SHE HAD A COMPOSIX KUGEL MESH IMPLANTED FOR MIDLINE HERNIA REPAIR (TYPE UNKNOWN). IN 2009 - 2010 - PATIENT STATES SHE HAD CONSULTATION WITH SURGEON INQUIRING ABOUT EXPLANT OF MESH. SURGEON SAID TO HAVE TOLD PATIENT EXPLANT WOULD BE "LIFE THREATENING" DUE TO ADHESIONS TO BOWEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S