BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIARC SINGLE INCISION SLING SYSTEM

    MDR report key: 3213721 · Received July 3, 2013

    Report

    Report Number
    2183959-2013-00914
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    April 18, 2013
    Report Date
    June 11, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    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

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A MINIARC SLING. AFTER IMPLANTATION, THE PATIENT EXPERIENCED PAIN, DYSPAREUNIA, AND "DESIRED REMOVAL" OF THE DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304221 MINIARC SINGLE INCISION SLING SYSTEM SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention