BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ELEVATE PC ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

    MDR report key: 3820621 · Received May 20, 2014

    Report

    Report Number
    2183959-2014-00168
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    December 31, 2013
    Report Date
    May 16, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    OTP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF AN ELEVATE PC ANTERIOR, THE PATIENT EXPERIENCED WORSENING MIXED URINARY INCONTINENCE. A PROCEDURE WAS PERFORMED ON (B)(6) 2014 TO PLACE TRANS-OBTURATOR TAPE TO TREAT THE URINARY INCONTINENCE. THE EVENT IS CONSIDERED CONTINUING (NOT RESOLVED) AS OF (B)(6) 2014. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300260 AMS ELEVATE PC ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE SURGICAL MESH OTP AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability