BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEANIC

    MDR report key: 3201887 · Received July 2, 2013

    Report

    Report Number
    8020994-2013-00002
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 25, 2013
    Manufacturer
    KERRHAWE
    Product Code
    EJR
    PMA / PMN Number
    P923020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE PATIENT IS DOING FINE. THE DOCTOR PRESCRIBED CORTISONE FOR THE PATIENT, WITHOUT FURTHER INCIDENT. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED; THEREFORE, NO EVALUATIONS CAN BE CONDUCT. NO FURTHER EVALUATIONS NEEDED SINCE AN ALLERGIC REACTION COULD NOT BE REPLICATED.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT A PATIENT HAD EXPERIENCED AN ALLERGIC REACTION WITH SYMPTOMS OF THROAT IRRITATION, RASHES ON HANDS, FEET, AND GLUTEAL AFTER RECEIVING TREATMENT WITH CLEANIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301257 CLEANIC AGENT, POLISHING, ABRASIVE, ORAL CAVITY EJR KERRHAWE 4625004

    Patients

    Seq Age Sex Outcome Treatment
    1 40 Hospitalization| O| R PRO CUP| CLEANING LAB LIGHT