BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3678805 · Received March 7, 2014

    Report

    Report Number
    3678805
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    November 16, 2013
    Report Date
    March 7, 2014
    Manufacturer
    ADDTO, INC.
    Product Code
    EYI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CATHETER ADAPTER BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139072 * ADAPTOR, URETERAL CATHETER EYI ADDTO, INC. * 534

    Patients

    Seq Age Sex Outcome Treatment
    1 *