BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY SCANNER 2006

    MDR report key: 2942428 · Received February 4, 2013

    Report

    Report Number
    2016150-2013-00001
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Report Date
    January 3, 2013
    Manufacturer
    SYBRONENDO
    Product Code
    EAT
    PMA / PMN Number
    K990225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WITH REGARD TO AGE AND WEIGHT WERE NOT PROVIDED. IT WAS INITIALLY REPORTED BY A DEALER REPRESENTATIVE THAT NO INJURY WAS ASSOCIATED WITH THIS INCIDENT. DURING A FOLLOW UP PHONE CALL ON (B)(4) 2013 WITH THE DEALER REPRESENTATIVE, IT WAS REPORTED THAT THE SHOCK THE DOCTOR HAD RECEIVED WAS "A SURPRISE", BUT WAS NOT PAINFUL AT ALL. UPON FURTHER EVALUATION OF THE COMPLAINT, THE DEALER REPRESENTATIVE WAS CONTACTED A SECOND TIME ON (B)(4) 2013 AND THE CUSTOMER'S CONTACT INFORMATION WAS REQUESTED. DURING A FOLLOW UP PHONE CALL WITH THE DOCTOR'S OFFICE, IT WAS REVEALED THAT THE DOCTOR HAD REPORTED THE SHOCK SHE RECEIVED AS "EXTREMELY PAINFUL" WITH PAIN THAT HAD LASTED FOR A FEW DAYS FOLLOWING. NO MEDICAL ATTENTION OR PRESCRIPTION MEDICATION WAS REQUIRED; THE SYMPTOMS SUBSIDED ON THEIR OWN. TO DATE, THE DOCTOR HAS FULLY RECOVERED AND IS DOING FINE. THE DEVICE WAS RETURNED AND AN EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT SHE HAD RECEIVED A HIGH SHOCK WHILE TESTING THE VITALITY SCANNER 2006 UNIT ON HERSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47073 VITALITY SCANNER 2006 PULP TESTER EAT SYBRONENDO 26-42577

    Patients

    Seq Age Sex Outcome Treatment
    1 Other