BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SODIUM HYPOCHLORITE SOLUTION

    MDR report key: 4210401 · Received October 27, 2014

    Report

    Report Number
    2515379-2014-00069
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 25, 2014
    Manufacturer
    DSHEALTHCARE INC.
    Product Code
    KJJ
    PMA / PMN Number
    PRE-ADMEN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE PACKAGE LABELING AND DFU DETERMINED THAT THER ARE APPROPRIATE WARNINGS AND PRECAUTIONS. SODIUM HYPOCHLORITE IS A HAZARDOUS MATERIAL THAT IF INGESTED, COULD POTENTIALLY INTERACT WITH STOMACH ACIDS, RELEASING CHLORINE GAS. THEREFORE, IF INGESTION WERE TO RECUR, IT COULD NECESSITATE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION. THIS EVENT, THEREFORE, IS REPORTABLE PER 21 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 A PATIENT HAD INADVERTENTLY INGESTED A SMALL AMOUNT OF SODIUM HYDROCHLORIDE DURING A DENTAL PROCEDURE. THE PATIENT IMMEDIATELY EXPERIENCED A BURNING SENSATION. THE PATIENT WAS ADVISED TO DRINK MILK OR WATER AND TO SEEK MEDICAL ATTENTION. AFTER RINSING WITH WATER, THE PATIENT FELT BETTER AND DID NOT SEEK MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681778 SODIUM HYPOCHLORITE SOLUTION ROOT CANAL CLEASNER KJJ DSHEALTHCARE INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other