BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOJECT 450 SAL EJECTOR 3283

    MDR report key: 615956 · Received June 6, 2005

    Report

    Report Number
    9612030-2005-00009
    Event Type
    Malfunction
    Date Received
    June 6, 2005
    Report Date
    June 6, 2005
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    DZM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDAL IN JUNE 2005 THAT A CUSTOEMR HAD A PROBLEM WITH THE CO'S DENTAL INJECTORS. THE CUSTOMER ALLEGES THAT THE TIPS ARE DETACHING FROM THE TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOJECT 450 SAL EJECTOR 3283 DENTAL PRODUCT DZM TYCO HEALTHCARE/KENDALL 450 EJECTORS 415206064

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN