BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION

    MDR report key: 4606389 · Received March 13, 2015

    Report

    Report Number
    2515379-2015-00013
    Event Type
    Injury
    Date Received
    March 13, 2015
    Date of Event
    February 13, 2015
    Report Date
    February 13, 2015
    Manufacturer
    DENTSPLY TULSA DENTAL SPECIALITIES
    Product Code
    KJJ
    PMA / PMN Number
    K103244
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT WHILE USING QMIX, A PATIENT BEGAN EXPERIENCING A TINGLING AND BURNING SENSATION AROUND THE SITE. THE DOCTOR VACUUMED OUT THE QMIX AND THE PATIENT BEGAN EXPERIENCING SWELLING OF THE LIP, THEN NOSE AND BY THE SECOND DAY THE PATIENT'S EYE HAD SWOLLEN SHUT. IT IS UNKNOWN IF THE PATIENT REQUIRED INTERVENTION. FOLLOW UP IS NOT YET COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172778 QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION KJJ DENTSPLY TULSA DENTAL SPECIALITIES UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other