BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

    MDR report key: 3872162 · Received June 13, 2014

    Report

    Report Number
    2183959-2014-00219
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    July 7, 2013
    Report Date
    May 28, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    OTP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS IMPLANTED WITH AN ELEVATE PC APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM ON (B)(6) 2013. HE PATIENT EXPERIENCED PAIN, FATIGUE, DYSURIA AND A URINARY TRACT INFECTION ON (B)(6) 2013. THE PATIENT WAS TREATED WITH ANTIBIOTICS FOR 7 DAYS. THE EVENT RESOLVED ON (B)(6) 2013. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349706 AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE SURGICAL MESH OTP AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention