BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCHEIN DENTAL ULTIMA 5000 II SE

    MDR report key: 354741 · Received August 21, 2001

    Report

    Report Number
    MW4003116
    Event Type
    Malfunction
    Date Received
    August 21, 2001
    Date of Event
    April 1, 2001
    Report Date
    August 21, 2001
    Manufacturer
    ULTIMA DENTAL SYSTEMS
    Product Code
    EHZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE SUCTION HOSE OF THE MOBILE DENTAL CART BECOMES SEPARATED, REVERSING THE AIR FLOW. THIS RESULTS IN EXPELLING OF CONTENTS OF THE COLLECTION RECEPTACLE, POSSIBLY CONTAMINATING PTS AND MEDICAL PERSONNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38650 SCHEIN DENTAL ULTIMA 5000 II SE SUCTION HOSE EHZ ULTIMA DENTAL SYSTEMS NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO