BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVANCE MALE SLING SYSTEM

    MDR report key: 2960232 · Received February 8, 2013

    Report

    Report Number
    2183959-2013-00645
    Event Type
    Injury
    Date Received
    February 8, 2013
    Report Date
    January 31, 2013
    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 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 PT HAD AN INVANCE SLING IMPLANTED ON (B)(6) 2006. FOLLOWING THE IMPLANT THE PT HAD INCONTINENCE THAT WAS WORSE THAN BASELINE AND ANOTHER CONTINENCE DEVICE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54115 INVANCE MALE SLING SYSTEM SURGICAL MESH FTL AMERICAN MEDICAL SYSTEMS, INC. 442453

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability