BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIARC SLING SYSTEM

    MDR report key: 3121948 · Received May 15, 2013

    Report

    Report Number
    2183959-2013-00833
    Event Type
    Injury
    Date Received
    May 15, 2013
    Report Date
    February 11, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    A MINIARC SLING WAS IMPLANTED IN 2009 TO TREAT URINARY INCONTINENCE. IT WAS REPORTED THAT PT HAD A FOLLOW-UP 3-6 MONTHS AFTERWARDS, IN WHICH THE PHYSICIAN DISCOVERED A SMALL MESH EXTRUSION. THE PHYSICIAN OFFERED TREATMENT OPTIONS WHICH THE PT DECLINED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215334 MINIARC SLING SYSTEM SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention