BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEANFREAK DUAL ENDED CLEANING BRUSH

    MDR report key: 9383522 · Received November 26, 2019

    Report

    Report Number
    MW5091319
    Event Type
    Malfunction
    Date Received
    November 26, 2019
    Date of Event
    November 13, 2019
    Report Date
    November 21, 2019
    Manufacturer
    MEDOVATIONS / DIVERSATEK HEALTHCARE INC.
    Product Code
    MNL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN CLEANING A COLONOSCOPE (SN# (B)(4)), A SECTION OF THE BRUSH BROKE OFF. BROKEN COMPONENT DID NOT COME OUT "INITIALLY", BUT AFTER NUMEROUS TIMES IT DID. THE SECTION IS ABOUT 12" LONG. SCOPE SENT TO MFR TO VERIFY "MU" HAS BEEN REMOVED AND NO DAMAGE TO THE SCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174685 CLEANFREAK DUAL ENDED CLEANING BRUSH ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE MNL MEDOVATIONS / DIVERSATEK HEALTHCARE INC. 1200.04 001892

    Patients

    Seq Age Sex Outcome Treatment
    1