BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30 G SHORT PLASTIC

    MDR report key: 1982123 · Received January 14, 2011

    Report

    Report Number
    1017768-2011-00002
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Report Date
    January 13, 2011
    Manufacturer
    COVIDIEN
    Product Code
    DZM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    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 STATES THE DOCTOR IS BENDING THE NEEDLE PRIOR TO USE AND REPORTED THE NEEDLE BREAKING OFF AT THE HUB. NO PATIENT INVOLVEMENT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 30 G SHORT PLASTIC DENTAL NEEDLE DZM COVIDIEN 8881400074 024941

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN