BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30G DENTAL NDL

    MDR report key: 1344007 · Received January 14, 2009

    Report

    Report Number
    1017768-2009-00024
    Event Type
    Malfunction
    Date Received
    January 14, 2009
    Date of Event
    January 5, 2009
    Report Date
    January 5, 2009
    Manufacturer
    COVIDIEN
    Product Code
    DZM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 01/12/2009. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN IN 2009, THAT A CUSTOMER HAD AN ISSUE WITH DENTAL NEEDLE. THE CUSTOMER REPORTS THE NEEDLE BROKE IN THE PATIENT AND WAS DIFFICULT TO RETRIEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 30G DENTAL NDL DENTAL NEEDLE DZM COVIDIEN 8881401072 514621

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK