BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIARC SLING SYSTEMS

    MDR report key: 1780956 · Received July 27, 2010

    Report

    Report Number
    2183959-2010-00319
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    April 1, 2009
    Report Date
    July 14, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE IFU DOES NOT LIST CHRONIC CYSTITIS UNDER POTENTIAL ADVERSE EVENTS. "WARNINGS AND PRECAUTIONS" STATES THAT VAGINAL OR URINARY TRACT INFECTION SHOULD BE TREATED PRIOR TO IMPLANTATION. NO DEVICE MALFUNCTION INDICATED AND THE DEVICE WAS NOT EXPLANTED.

    Description of Event or Problem · 1

    POST MARKET CLINICAL STUDY PT WAS IMPLANTED WITH MINIARC ON (B)(6) 2008. (PT HAS A HISTORY OF URINARY TRACT INFECTIONS). ON (B)(6) 2010, THE PHYSICIAN REPORTED PAIN/DISCOMFORT-OTHER-CHRONIC CYSTITIS. THE PHYSICIAN REPORTED THE EVENT IS RELATED TO THE DEVICE AND THE PROCEDURE. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIARC SLING SYSTEMS SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC. 720046-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Disability