BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIARC SLING

    MDR report key: 2172608 · Received July 19, 2011

    Report

    Report Number
    2183959-2011-00260
    Event Type
    Injury
    Date Received
    July 19, 2011
    Report Date
    July 1, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFO BECOMES AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    RELATED TO MFR REPORT #2183959-2011-00263. ON (B)(6) 2011, A MINIARC SLING WAS IMPLANTED FOR INCONTINENCE. ADDITIONAL INFO RECEIVED INDICATES THAT ON (B)(6) 2011, THE PT UNDERWENT "EXTIRPATION" OF VERY SMALL AREAS OF MESH EROSION. THE PT IS REPORTED TO BE DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention ELEVATE ANTERIOR