BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOARC SLING SYSTEM

    MDR report key: 2770372 · Received October 1, 2012

    Report

    Report Number
    2183959-2012-02831
    Event Type
    Injury
    Date Received
    October 1, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 14, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 A BIOARC SLING SYSTEM WAS IMPLANTED ON (B)(6) 2012. DURING THE PROCEDURE, MESH WAS SEEN IN THE BLADDER WHEN THE SURGEON "PULLED THE MESH THROUGH." THE DEVICE WAS REMOVED AND A NEW BIOARC DEVICE WAS IMPLANTED. THE PATIENT WAS REPORTED TO BE DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R