BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM CUFF AMS 800 ARTIFICIAL URETHRAL SPHINCTER 4.0

    MDR report key: 2922305 · Received January 11, 2013

    Report

    Report Number
    MW5028634
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 26, 2012
    Report Date
    January 11, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FAG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE TANDEM CUFF AMS 800 ARTIFICIAL URETHRAL SPHINCTER THAT WAS INSERTED (B)(6) 2010 HAD TO BE REPLACED ON (B)(6) 2012 BECAUSE IT WAS FOUND TO BE EXPOSED WITHIN THE BLADDER ITSELF AND A NONFUNCTIONING ARTIFICIAL URINARY SPHINCTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18820 TANDEM CUFF AMS 800 ARTIFICIAL URETHRAL SPHINCTER 4.0 ARTIFICIAL URINARY SPHINCTER FAG AMERICAN MEDICAL SYSTEMS, INC. 628809017

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention