BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SANAO

    MDR report key: 4693912 · Received March 20, 2015

    Report

    Report Number
    2529090-2015-19942
    Event Type
    Injury
    Date Received
    March 20, 2015
    Date of Event
    February 18, 2015
    Report Date
    February 18, 2015
    Manufacturer
    SCICAN GMBH
    Product Code
    EGS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DURING A DENTAL PROCEDURE ON A PATIENT USING THE SANAO CONTRA ANGLE DENTAL HANDPIECE, THE DENTIST NOTICED THAT THE PATIENTS TONGUE WAS WHITE AND ASSUMED THAT IT WAS TOOTH DUST THE PATIENT COMPLAINED DURING PROCEDURE. PATIENT RETURNED TO THE OFFICE TO COMPLAIN LATER IN THE DAY AFTER THE ANESTHETIC WORE OFF. THE INCIDENT OCCURRED THURSDAY (B)(6) 2015. THE PATIENT WENT TO A PHYSICIAN ON (B)(6) 2015 AND WAS PRESCRIBED PENICILLIN. ACCORDING TO AN E-MAIL FROM THE DEALER, (B)(4), TO THE IMPORTER, SCICAN INC., THE PATIENT IS DOING FINE. THE FOLLOWING SAFETY INFORMATION HAS BEEN PROVIDED IN THE IFU WITH REGARD TO THE USE OF ELECTRIC MICRO-MOTORS: "RISKS WHEN USING HANDPIECES WITH ELECTRICAL MICRO-MOTORS. ELECTRICAL MICRO-MOTORS GENERATE SIGNIFICANTLY MORE ENERGY THAN CONVENTIONAL AIR TURBINES AND AIR MOTORS. DUE TO THE HIGH TORQUES AND SPEEDS, POORLY SERVICED, DAMAGED OR MISUSED HANDPIECES MAY LEAD TO OVERHEATING WHICH COULD INFLICT SEVERE BURNS ON THE PATIENT. " MFR REF# 3006028656-2015-00923.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190571 SANAO HANDPIECE, ATTACHMENT, DENTAL EGS SCICAN GMBH S20100

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention