BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SODIUM HYPOCHLORITE 16 OZ. (473 ML)

    MDR report key: 5684267 · Received May 27, 2016

    Report

    Report Number
    2515379-2016-00015
    Event Type
    Injury
    Date Received
    May 27, 2016
    Report Date
    April 28, 2016
    Manufacturer
    DENTSPLY CAULK
    Product Code
    KJJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LOT NUMBER WAS PROVIDED AND RETAINED-PRODUCT TESTING AND/OR DHR REVIEW ARE PLANNED. THE RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    RETAIN PRODUCT WAS EVALUATED AND FOUND TO BE WITHIN SPECIFICATION. ALSO, A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ALLERGIC REACTION TO SODIUM HYPOCHLORITE. THE REPORTED SYMPTOMS INCLUDE PAIN, SWELLING AND REDNESS FROM THE SUB ORBITAL AREA TO THE BOARDER OF THE MANDIBLE. THE CLINICIAN REPORTED THAT THE PATIENT SOUGHT MEDICAL ATTENTION FOR THE REACTION, BUT DID NOT INDICATE WHAT THE TREATMENT WAS. THE PATIENT'S SYMPTOMS HAVE IMPROVED SINCE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340302 SODIUM HYPOCHLORITE 16 OZ. (473 ML) CLEANSER, ROOT CANAL KJJ DENTSPLY CAULK NA 1504151

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention