BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY SCANNER 2006

    MDR report key: 3985166 · Received August 6, 2014

    Report

    Report Number
    2016150-2014-00435
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Report Date
    July 8, 2014
    Manufacturer
    SYBRONENDO
    Product Code
    EAT
    PMA / PMN Number
    K990225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT. NO MEDICAL ATTENTION OR PRESCRIPTION MEDICATION WAS NECESSARY. NO SYMPTOMS WERE REPORTED BY THE PATIENT. TO DATE, THE PATIENT IS DOING FINE. A VISUAL AND PHYSICAL EVALUATION WAS PERFORMED ON THE RETURNED UNIT. IT WAS DISCOVERED THAT THE BATTERY SNAP WAS DISCONNECTED FROM THE UNIT AND THE WHEEL LABEL WAS COMING OFF.

    Description of Event or Problem · 1

    A DOCTOR'S OFFICE ALLEGED THAT THE VITALITY SCANNER 2006 HAD SHOCKED A PATIENT DURING A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459145 VITALITY SCANNER 2006 PULP TESTER EAT SYBRONENDO

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other