BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 3733805 · Received March 26, 2014

    Report

    Report Number
    1213643-2014-00084
    Event Type
    Injury
    Date Received
    March 26, 2014
    Report Date
    March 3, 2014
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE CURRENTLY AVAILABLE INFORMATION WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY, A BARD DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS ALLEGED. THE INFORMATION PROVIDED WAS LIMITED, WE HAVE REQUESTED ADDITIONAL INFORMATION. WITHOUT A LOT NUMBER A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL VIA MAUDE EVENT REPORT (B)(4): THE PT ALLEGED VIA MAUDE EVENT REPORT THAT IN 2010 HE UNDERWENT LAPAROSCOPIC RIGHT ILIOINGUINAL HERNIA REPAIR WITH A BARD FLAT MESH. HE ALLEGES THAT HE HAS HAD HEALTH ISSUES SINCE SURGERY AND HAS BEEN ON WORKMAN'S COMP SINCE 2011. INFORMATION IS LIMITED AS THE PT HAS NOT RESPONDED TO OUR REQUESTS FOR ADDITIONAL INFORMATION. AS THE PT HAS ALLEGED UNSPECIFIED HEALTH ISSUES DUE TO THE MESH IMPLANT, THERE IS A POSSIBILITY FOR MEDICAL TREATMENT/SURGICAL INTERVENTION AN MDR IS BEING FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176475 BARD FLAT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention| S