BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 5564984 · Received April 8, 2016

    Report

    Report Number
    1213643-2016-00134
    Event Type
    Injury
    Date Received
    April 8, 2016
    Report Date
    March 15, 2016
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE OR PATIENT INJURY AND MEDICAL RECORDS WERE LIMITED TO THE PATIENT'S IMPLANT OPERATIVE REPORT AND IMPLANT TRACKING LOG. A MANUFACTURING REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE ALLEGED EVENT. IF ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON A REVIEW OF LIMITED MEDICAL RECORDS AND THE ATTORNEY'S LEGAL CLAIM PROVIDED TO DAVOL BY THE PATIENT'S ATTORNEY: (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH STRESS URINARY INCONTINENCE, CYSTOCELE AND UNDERWENT A MARSHALL-MARCHETTI-KRANTZ PROCEDURE WITH IMPLANT OF A BARD/DAVOL "MONOFILAMENT NYLON" FLAT MESH. THE ATTORNEY ALLEGES THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME ASSOCIATED TO THE USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219926 BARD FLAT MESH SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. HUTE0950

    Patients

    Seq Age Sex Outcome Treatment
    1 Other