BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXELINT INTERNATIONAL CO

    MDR report key: 1055511 · Received June 2, 2008

    Report

    Report Number
    MW5007115
    Event Type
    Malfunction
    Date Received
    June 2, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 2, 2008
    Manufacturer
    EXELINT INTERNATIONAL CO.
    Product Code
    DZM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    NEEDLE FAILS TO ADEQUATELY ENGAGE THE HUB SO IN USE IT CAN AND HAS FALLEN OFF THE SYRINGE. THIS HAS HAPPENED TO SEVERAL OF THESE NEEDLES LIMITED TO THIS ONE MFR. DATES OF USE: #1 2008, #2: 2008. DIAGNOSIS: ADMINISTER ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXELINT INTERNATIONAL CO SUPERJECT DENTAL NEEDLE 30G LONG DZM EXELINT INTERNATIONAL CO. 30G LONG DENTAL 03H26

    Patients

    Seq Age Sex Outcome Treatment
    1