BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUPRO PROPHY PASTE

    MDR report key: 1516302 · Received October 22, 2009

    Report

    Report Number
    2515379-2009-00145
    Event Type
    Injury
    Date Received
    October 22, 2009
    Date of Event
    September 17, 2009
    Report Date
    September 22, 2009
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EJR
    PMA / PMN Number
    K912945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNKNOWN IF THE NUPRO 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 IS REPORTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED BOTH GINGIVAL IRRITATION AND A FACIAL RASH THE DAY AFTER A DENTAL PROCEDURE, DURING WHICH NUPRO WAS USED. THERE IS NO INDICATION THAT INTERVENTION WAS REQUIRED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUPRO PROPHY PASTE EJR DENTSPLY PROFESSIONAL NA 08072302

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other DENTAL PLAQUE REMOVAL FLUID| CHLORINE-HEXAMED-GEL| ELMEX-GEL