BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30G DENTAL NDL

    MDR report key: 2170842 · Received June 22, 2011

    Report

    Report Number
    1017768-2011-00019
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 24, 2011
    Report Date
    June 22, 2011
    Manufacturer
    COVIDIEN
    Product Code
    DZM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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) 2011 THAT A CUSTOMER HAD AN ISSUE WITH A DENTAL NEEDLE. THE CUSTOMER REPORTS THAT DURING A MANDIBULAR INJECTION ON A PT, THE NEEDLE BROKE FROM THE HUB AND REMAINED IN THE PT'S TISSUE. THE CUSTOMER WAS ABLE TO LOCATE THE NEEDLE BY RUNNING HIS FINGER OVER THE TISSUE, THEN USED FORCEPS TO REMOVE THE NEEDLE. NO FURTHER MEDICAL INTERVENTION OR IMPACT 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 025923

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK