BEUDAMED
    FDA Adverse Event Other Summary report: N

    NUPRO PROPHY PASTE MINT

    MDR report key: 485808 · Received September 27, 2003

    Report

    Report Number
    2424472-2003-00147
    Event Type
    Other
    Date Received
    September 27, 2003
    Date of Event
    August 5, 2003
    Report Date
    August 12, 2003
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THAT A PATIENT EXPERIENCED PROBLEMS BREATHING AND SWELLING AFTER CONTACT WITH NUPRO PROPHY PASTE. CONTINUED EFFORTS TO OBTAIN MORE PATIENT INFORMATION HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUPRO PROPHY PASTE MINT CLEANING PASTE EJR DENTSPLY PROFESSIONAL NA 01111906

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other