BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30G DENTAL NDL

    MDR report key: 1854518 · Received September 30, 2010

    Report

    Report Number
    1017768-2010-00020
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 28, 2010
    Manufacturer
    COVIDIEN
    Product Code
    DZM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: (B)(4) 2010. AN INVESTIGATION IS CURRENTLY UNDERWAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A DENTAL NEEDLE. THE CUSTOMER REPORTS THAT THE END USER, A DENTIST, REPORTED THAT THE NEEDLE BROKE IN THE GUM OF THE PT WHILE INJECTING THE ANESTHETIC IN THE PT'S MOUTH. THE NEEDLE WAS SUCCESSFULLY REMOVED FROM THE PT'S GUM. NO ILL EFFECT TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 30G DENTAL NDL DENTAL NEEDLE DZM COVIDIEN 8881401072 004639

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK