BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUPRO PROPHY PASTE

    MDR report key: 4279199 · Received November 22, 2014

    Report

    Report Number
    2424472-2014-00011
    Event Type
    Injury
    Date Received
    November 22, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 17, 2014
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EJR
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNKNOWN IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT'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 EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    A CHEMTREC EMERGENCY INCIDENT REPORT WAS RECEIVED THAT REPORTED A PEDIATRIC PATIENT WAS TREATED WITH NUPRO PROPHY PASTE WITH FLUORIDE AND LATER EXPERIENCED A RASH. THERE WAS NO REPORT OF INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758988 NUPRO PROPHY PASTE ORAL CAVITY ABRASIVE POLISHING AGENT EJR DENTSPLY PROFESSIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other