BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BENCO PL. 30 GA NEEDLE

    MDR report key: 1080823 · Received June 26, 2008

    Report

    Report Number
    2529586-2008-00001
    Event Type
    Injury
    Date Received
    June 26, 2008
    Date of Event
    January 1, 2007
    Report Date
    September 25, 2007
    Manufacturer
    S.O.F.I.C. S.A.
    Product Code
    DZM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE BENCO PL. 30 GAUGE SHORT NEEDLE THAT THE DENTIST WAS USING TO INJECT THE TEENAGE MALE PT WITH DENTAL ANESTHETIC BROKE AT THE HUB WHILE INSIDE THE PT'S MOUTH. DENTIST WAS UNABLE TO REMOVE THE NEEDLE. PT THEN WENT TO AN ORAL SURGEON, WHO WAS UNABLE TO REMOVE THE NEEDLE DURING TWO SEPARATE SURGERIES. A SECOND ORAL SURGEON ALSO TRIED TO REMOVE THE NEEDLE, BUT WAS CONCERNED ABOUT ITS PROXIMITY TO THE PT'S JUGULAR VEIN AND WAS NOT ABLE TO DO SO. FINALLY, THE NEEDLE WAS REMOVED AT EMORY HOSP. THE TREATING DENTIST REPORTED THIS EVENT TO DENTAL DEALER. THERE IS SOME CONFUSION ABOUT THE LOT NUMBER REPORTED BY THE DENTIST: SHE REPORTED THAT THE NEEDLE WAS LABELED WITH LOT # 070306, BUT THAT LOT WAS NOT DISTRIBUTED UNTIL FOUR MONTHS AFTER THE DATE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BENCO PL. 30 GA NEEDLE DENTAL NEEDLE DZM S.O.F.I.C. S.A. N1301 070306

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| R