BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SODIUM HYPOCHLORITE

    MDR report key: 4495743 · Received February 6, 2015

    Report

    Report Number
    2515379-2015-00002
    Event Type
    Injury
    Date Received
    February 6, 2015
    Date of Event
    May 1, 2014
    Report Date
    January 6, 2015
    Manufacturer
    DENTSPLY CAULK
    Product Code
    KJJ
    PMA / PMN Number
    PREAMEND
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DR THOUGHT THAT THE PT MAY HAVE EXPERIENCED AN ALLERGIC REACTION TO THE SODIUM HYPOCHLORITE. HOWEVER, THE SYMPTOMS DESCRIBED ARE MORE CONSISTENT WITH COMPLICATIONS ARISING FROM THE SODIUM HYPOCHLORITE BEING EXTRUDED BEYOND THE ROOT APEX. DUE TO THE PERMANENT LOSS OF THE TOOTH, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVAL, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVAL RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT AFTER USE OF SODIUM HYPOCHLORITE DURING A ROOT CANAL THERAPY PROCEDURE, A PT EXPRESSED THAT THEY WERE IN PAIN. THE NEXT DAY, THE PT RETURNED TO THE DENTIST AND THEIR FACE WAS SWOLLEN FROM THE JAW DOWN TO THE NECK AREA. THE PTS' TOOTH HAD TO BE EXTRACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87224 SODIUM HYPOCHLORITE CLEANSER, ROOT CANAL KJJ DENTSPLY CAULK 131218

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability