BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DETREY CONDITIONER 36

    MDR report key: 2227005 · Received August 19, 2011

    Report

    Report Number
    8010638-2011-00011
    Event Type
    Injury
    Date Received
    August 19, 2011
    Report Date
    July 22, 2011
    Manufacturer
    DENTSPLY DETREY
    Product Code
    EBC
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS POSSIBLE THAT PROLONGED SKIN / ORAL MUCOSA CONTACT WITH PHOSPHORIC ACID COULD RESULT IN BURNING, IRRITATION, SENSITIZATION, AND OTHER SYMPTOMS. THE DIRECTIONS FOR USE CLEARLY ADDRESS THE POSSIBLE EFFECTS OF ORAL MUCOSA AND SKIN CONTACT AND PROVIDE PREVENTIVE AND CORRECTIVE MEASURES. FURTHERMORE, THIS EVENT IS RELATED TO USE-ERROR AND IS NOT THE RESULT OF A MALFUNCTION OF THE SYRINGE. PLEASE NOTE THAT THE DEVICE INVOLVED IS NOT SOLD IN THE US. HOWEVER, IT IS CONSIDERED SIMILAR TO DEVICES THAT ARE BASED ON ITS COMPOSITION AND SYRINGE DELIVERY MECHANISM. THEREFORE, BECAUSE A SERIOUS HISTORY INJURY OCCURRED, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT TWO PTS EXPERIENCED BURNING, WHITE DISCOLORATION AND ABLATION OF THE GINGIVAL IMMEDIATELY AFTER CONTACT WITH DETREY CONDITIONER 36. BOTH PTS WERE TREATED WITH KAMISTAD GEL. ONE PT STATED THE PAIN OCCURRED FOR SEVERAL MINUTES. THE OTHER PT RETURNED TO THE DENTIST'S OFFICE TWO DAYS LATER AND HE WAS TREATED WITH VOLON-A AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DETREY CONDITIONER 36 EBC DENTSPLY DETREY 1004000712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention