BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS 800 CUFF

    MDR report key: 2921431 · Received January 16, 2013

    Report

    Report Number
    2921431
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 16, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    EZY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE SURGICAL REPORT, "...ON CYSTOSCOPY HE HAD AN OBVIOUS EROSION OF THE CUFF INTO THE URETHRA." THIS LED TO URINARY INCONTINENCE AND REQ'D (REQUIRED) THE REMOVAL OF THE CUFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25045 AMS 800 CUFF DEVICE, INCONTINENCE, MECHANICAL/HYDRAULIC EZY AMERICAN MEDICAL SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR