BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX POINTER+

    MDR report key: 9579315 · Received January 11, 2020

    Report

    Report Number
    8030962-2017-00001
    Event Type
    Injury
    Date Received
    January 11, 2020
    Date of Event
    October 10, 2017
    Report Date
    November 21, 2017
    Manufacturer
    MICRO-MEGA SOCIETE ANONYME
    Product Code
    LQY
    PMA / PMN Number
    K103123
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DECLARATION IS BASED ON PHOTO SENT TO US. THIS PHOTO IS SHOWING TRACES ON THE CHEEK OF THE PATIENT. THE DENTIST THINKS IT COULD BE LINKED TO THE USE OF THE APEX LOCATOR. MICRO-MEGA IS NOT SURE THAT THE TRACES IS A BURN OR AN IRRITATION OR AN ALLERGY. ALSO, WE ARE NOT SURE THAT THIS INJURY IS DUE TO THE DEVICE APEX POINTER +. THE DENTIST MADE A LOCAL TREATMENT TO TREAT TRACES: PHYSIOLOGICAL SERUM AND VASELINE; THROUGH OUR INFORMATION'S, NO OTHER ACTIONS HAVE BEEN DONE BY HEALTH PROFESSIONAL. THE DEVICE HAS BEEN TESTED IN OUR FACILITIES: NO PROBLEM HAS BEEN DETECTED. NOTE: THE DEVICE IS POWERED BY BATTERY (MAX 6 V DC) - DATE (B)(6) 2017. IT IS THE FIRST CASE THAT WE BECAME AWARE. THIS DEVICE IS NOT MARKETING ANY MORE. SO WE DID NOT ENGAGE ANY ACTIONS.

    Description of Event or Problem · 1

    24 HOURS AFTER DENTAL TREATMENT USING AN APEX LOCATOR, THERE APPEARED TRACES RESSEMBLING TO AN ALLERGY OR IRRITIAION ON THE EXTERNAL SIDE OF THE PATIENT CHEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42200 APEX POINTER+ APEX POINTER+ LQY MICRO-MEGA SOCIETE ANONYME

    Patients

    Seq Age Sex Outcome Treatment
    1 Other