BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELIPAR HIGHLIGHT

    MDR report key: 176158 · Received July 8, 1998

    Report

    Report Number
    9611385-1998-00004
    Event Type
    Malfunction
    Date Received
    July 8, 1998
    Date of Event
    March 4, 1998
    Report Date
    June 17, 1998
    Manufacturer
    ESPE DENTAL-MEDIZIN GMBH & CO.KG.
    Product Code
    EAY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ON JUNE 10TH, A DENTIST CALLED AND REPORTED OF BURNING-BLISTERING AT THE GINGIVA AROUND A TOOTH AFTER APPLICATION OF ELIPAR HIGHLIGHT FOR LIGHT CURING OF A COMPOSITE RESTORATIVE MATERIAL, WHICH THE DENTIST BELIEVED MAY HAVE BEEN DUE TO THE DEVELOPMENT OF HEAT DURING THE APPLICATION OF THE LIGHT SOURCE. THE PT WAS TREATED BY COOLING THE GINGIVE, FOLLOWED BY IRRIGATING WITH CHLORHEXAMED. AFTER ONE WEEK THE PT'S GINGIVE HAS BEEN COMPLETELY RECOVERED. ALTHOUGH THE EVENT OCCURRED ON MARCH 4, 1998, ESPE WAS NOT NOTIFIED UNTIL JUNE 10. DUE TO THE PT'S DEEP CAVITY, THE DENTIST PERFORMED A SUBGINGIVAL DISSECTION USING RETRACTION FIBERS. TWO PINS WERE INSERTED INTO THE ROOT CANAL AND COATED WITH - PROBABLY 2 LAYERS OF - VIVADENT'S TETRIC COMPOSITE RESTORATIVE MATERIAL. LIGHT CURING WAS UNDERTAKEN TWO TIMES (40 SECONDS EACH TIME). THE "ONE-STEP MODUS" WAS USED AT THE HIGHEST LIGHT INTENSITY. THE TOOTH SUBSEQUENTLY WAS CROWNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELIPAR HIGHLIGHT LIGHT CURING UNIT EAY ESPE DENTAL-MEDIZIN GMBH & CO.KG. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other