BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ELEVATE PC ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

    MDR report key: 3853048 · Received June 6, 2014

    Report

    Report Number
    2183959-2014-00201
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    June 19, 2013
    Report Date
    July 3, 2013
    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 EXPERIENCED DELAYED MICTURITION. AN ULTRASOUND WAS PERFORMED AND SHOWED RESIDUAL URINE IN THE BLADDER. A SUPRAPUBIC CATHETER WAS PLACED AND THE PATIENT WAS STARTED ON TAMSULOSIN. THE EVENT RESOLVED ON (B)(6) 2013. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION WITH THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THE SUPRAPUBIC CATHETER AND TAMSULOSIN TREATMENTS WERE STARTED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333115 AMS ELEVATE PC ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE SURGICAL MESH OTP AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R