BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOJECT 418 DENTAL INJECTOR 27SH

    MDR report key: 619893 · Received June 7, 2005

    Report

    Report Number
    1017768-2005-00027
    Event Type
    Malfunction
    Date Received
    June 7, 2005
    Report Date
    June 7, 2005
    Manufacturer
    TYCO HEALTHCARE/KENDALL
    Product Code
    DZM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL THAT A CUSTOMER EXPERIENCED A PROBLEM WITH THE CO'S DENTAL INJECTOR. THE CUSTOMER REPORTS THAT THE NEEDLE IS LOOSE IN THE HUB WHICH RESULTS IN NEEDLE DETACHMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOJECT 418 DENTAL INJECTOR 27SH 418 DENTAL INJECTOR DZM TYCO HEALTHCARE/KENDALL * 500764

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other