BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUPRO/SENSODYNE PASTE WITH FLUORIDE & NOVAMIN

    MDR report key: 2596746 · Received May 29, 2012

    Report

    Report Number
    2515379-2012-00008
    Event Type
    Injury
    Date Received
    May 29, 2012
    Report Date
    May 1, 2012
    Manufacturer
    DENTSPLY DETREY GMBH
    Product Code
    EJR
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNK IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PT'S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVAL, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVAL RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IN THIS EVENT, IT WAS REPORTED THAT TWO PTS EXPERIENCED AN ADVERSE REACTION IMMEDIATELY AFTER UNDERGOING A DENTAL PROPHYLAXIS THAT INCLUDED THE USE OF NUPRO/SENSODYNE POLISHING PASTE. AS STATED IN THE REPORT, TWO PTS EXPERIENCED IMMEDIATE SWELLING AND BLISTERING OF THE LIPS AND CHEEKS. PHOTOGRAPHS PROVIDED BY THE TREATING DENTIST CONFIRM THE PRESENCE OF BLISTER TYPE LESIONS ON THE LIP OF ONE OF THE PTS. THE DENTIST ADMINISTERED GENGIGEL MOUTHWASH TO COMBAT THE SYMPTOMS THE PTS EXPERIENCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUPRO/SENSODYNE PASTE WITH FLUORIDE & NOVAMIN EJR DENTSPLY DETREY GMBH 11101202

    Patients

    Seq Age Sex Outcome Treatment
    1 Other