BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS 800

    MDR report key: 1883946 · Received October 18, 2010

    Report

    Report Number
    1883946
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 18, 2010
    Manufacturer
    AMS
    Product Code
    EZY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE NOTES DIRECTLY FROM THE OPERATIVE REPORT STATE: THIS PATIENT PRESENTS WITH AN ARTIFICIAL SPHINCTER OVER A YEAR THAT HAS BEEN WORKING QUITE WELL, BUT PRESENTS WITH SOME INCONTINENCE AND A CYSTOSCOPY THAT CONFIRMS EROSION OF THE URETHRA. THERE IS A NEED TO HAVE IT REMOVED AND WE CAN HAVE IT REPLACED AT LATER TIME. THE DESCRIPTION OF THE PROCEDURE FOLLOWS: UNDER ANESTHESIA AFTER A FULL PREP, A PENAL SCROTAL SMALL INCISION WAS MADE OVER THE CUFF AND THE CUFF WAS REMOVED. THE PUMP WAS THEN BROUGHT INTO THIS INCISION AND INCISED WITH A CAUTERY AND THEN REMOVED AS WELL. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMS 800 ARTIFICIAL URINARY SPHINCTER EZY AMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR