BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEMI

    MDR report key: 1419197 · Received July 23, 2009

    Report

    Report Number
    3003848022-2009-00001
    Event Type
    Injury
    Date Received
    July 23, 2009
    Report Date
    June 25, 2009
    Manufacturer
    KERR CORPORATION
    Product Code
    EBZ
    PMA / PMN Number
    K071251
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    IN JULY OF 2009, THE DOCTOR WAS CONTACTED FOR MORE INFORMATION REGARDING THE INCIDENT. THE DOCTOR STATED THAT HE DID NOT USE THE PROTECTIVE LIGHT SHIELD WHICH PROTECTS THE EYES OF THE OPERATOR FROM THE LIGHT EMITTED FROM THE LIGHT GUIDE WHEN THE UNIT IS IN USE. THE SAFETY PRECAUTIONS SPECIFIED IN THE USER MANUAL STATE THAT SUITABLE EYE PROTECTION SHOULD BE WORN WHILE THE UNIT IS IN USE. THE DOCTOR DID NOT FOLLOW THIS WARNING. THE DOCTOR'S ALLEGATION THAT LIGHT EMITTED FROM THE DEMI CAUSED MACULAR DEGENERATION IS UNFOUNDED. THE WAVELENGTH OF UV RADIATION IS 286 - 400NM. UV RAYS WITHIN THIS RANGE ARE CONSIDERED HARMFUL AND CAN CAUSE MACULAR DEGENERATION. THE LIGHT EMITTED FROM THE DEMI HAS WAVELENGTHS OF 450 - 470NM WHICH IS WELL ABOVE THE UV RANGE AND COULD NOT HAVE CAUSED THE ALLEGED MACULAR DEGENERATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO KERR CORPORATION; THEREFORE, NO EVALUATION COULD BE CONDUCTED. THE DOCTOR STATES THAT WHEN HE USES THE DEMI, HE GETS BLURRY VISION IN THE MIDDLE OF HIS EYE THAT LASTS FOR SEVERAL HOURS. HE STATED THAT HE SAW A DOCTOR IMMEDIATELY UPON THE FIRST OCCURRENCE OF BLURRINESS, AND THE DOCTOR ALLEGES HE HAS MACULAR DEGENERATION. NO MEDICATION IS BEING TAKEN FOR THIS CONDITION.

    Description of Event or Problem · 1

    IN 2009, A DOCTOR INFORMED KERR CORPORATION THAT THE DEMI WAS AFFECTING HIS EYES. MORE SPECIFICALLY, BY MIDDAY HE WAS SEEING BLACK SPOTS.

    Description of Event or Problem · 1

    SEE MFR'S REPORT # 3007566237201001832 FOR INFO REGARDING THE PT'S INITIAL PUMP REPLACEMENT. ONE WEEK AFTER THE PT'S PUMP REPLACEMENT, THE PT'S INCISION WAS RED AND "PUFFY." THE PHYSICIAN TOLD HER THAT "IT WAS INFECTED." THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEMI ACTIVATOR,ULTRAVIOLET,FORPOLYMERIZATION EBZ KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other