BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ELEVATE PC ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

    MDR report key: 4091234 · Received September 16, 2014

    Report

    Report Number
    2183959-2014-00409
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    May 23, 2013
    Report Date
    September 4, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    OTP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO.

    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 THE PATIENT EXPERIENCED DYSPAREUNIA ON (B)(6) 2013 AND THE ELEVATE PC ANTERIOR DEVICE WAS REMOVED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING LOCAL ESTROGEN WAS PRESCRIBED ON (B)(6) 2013 AND WAS TO BE APPLIED THREE TIMES A WEEK. IT WAS ALSO STATED THAT THE MESH WAS PARTIALLY REMOVED ON (B)(6) 2013. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573409 AMS ELEVATE PC ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE SURGICAL MESH OTP AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S