BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

    MDR report key: 5112108 · Received September 29, 2015

    Report

    Report Number
    2183959-2015-00411
    Event Type
    Injury
    Date Received
    September 29, 2015
    Date of Event
    September 22, 2015
    Report Date
    September 27, 2015
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    OTP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF AN ELEVATE POSTERIOR, THE PATIENT EXPERIENCED MODERATE DIFFICULTY EMPTYING BLADDER. THE PATIENT WAS SENT HOME ON (B)(6) 2015 WITH A FOLEY CATHETER. THE PATIENT RETURNED TO THE CLINIC ON (B)(6) 2015 AND PASSED VOIDING TRIAL AND THE FOLEY CATHETER WAS REMOVED. THE EVENT WAS CONSIDERED RESOLVED/RECOVERED WITH NO SEQUELAE ON (B)(6) 2015. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641170 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 NATIVE TISSUE ENTEROCELE REPAIR