BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHLOR-XTRA

    MDR report key: 24027995 · Received January 9, 2026

    Report

    Report Number
    3000209941-2026-00001
    Event Type
    Injury
    Date Received
    January 9, 2026
    Report Date
    January 8, 2026
    Manufacturer
    INTER-MED, INC.
    Product Code
    KJJ
    UDI-DI
    20818207020479
    PMA / PMN Number
    K082470
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISTA APEX CONDUCTED A THOROUGH INVESTIGATION INTO THESE REPORTED EVENTS. REVIEW INCLUDED THE CLINICAL DETAILS PROVIDED BY THE EXPERIENCED ENDODONTIST, THE ORIGINAL BATCH TEST RESULTS, AND TESTING OF THE RETAINED SAMPLE. ALL PRODUCT TESTING, INCLUDING NAOCL CONCENTRATION, WAS WITHIN ESTABLISHED RELEASE SPECIFICATIONS. THE EVENTS ARE CONSISTENT WITH THE KNOWN, INHERENT CYTOTOXICITY OF SODIUM HYPOCHLORITE, WHICH IS REQUIRED FOR ITS INTENDED USE IN ROOT CANAL IRRIGATION. WHILE SODIUM HYPOCHLORITE EXTRAVASATION CAN THEORETICALLY RESULT FROM FACTORS SUCH AS ISOLATION TECHNIQUE OR PATIENT ANATOMY, NO PROCEDURAL DEVIATIONS WERE REPORTED, AND THE ENDODONTIST HAS OVER 20 YEARS OF EXPERIENCE WITH CONSISTENT TECHNIQUE AND EQUIPMENT. THE PRESENTATION AND RESOLUTION OF SYMPTOMS ALIGN WITH TYPICAL SODIUM HYPOCHLORITE INCIDENTS RATHER THAN A PRODUCT DEFECT, AND NO EVIDENCE OF BATCH-LEVEL OR BOTTLE-SPECIFIC CONTAMINATION WAS IDENTIFIED. THE SPECIFIC BOTTLE USED IN THESE PROCEDURES WAS NOT AVAILABLE FOR EVALUATION AT THE TIME OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SUBMITTED IF EVALUATION RESULTS IMPACT THE RISK ASSESSMENT, ELUCIDATE A DEFINITIVE ROOT CAUSE OR NEW FINDINGS, OR OTHERWISE INDICATE INACCURACIES IN THIS INITIAL REPORT.

    Description of Event or Problem · 0

    THIS REPORT DESCRIBES ONE OF THREE SIMILAR ADVERSE EVENTS REPORTED BY THE USER FACILITY TO HAVE OCCURRED WITHIN THE PAST 1-2 MONTHS DURING ENDODONTIC PROCEDURES USING CHLOR-XTRA SODIUM HYPOCHLORITE IRRIGANT. A 22-YEAR-OLD FEMALE DEVELOPED PAIN AND EXTERNAL FACIAL BRUISING FOLLOWING AN ENDODONTIC PROCEDURE IN WHICH CHLOR-XTRA WAS USED. THE EXACT DATE OF THE EVENT IS UNKNOWN. THE TREATING ENDODONTIST REPORTED THAT SYMPTOM ONSET AMONG THE THREE AFFECTED PATIENTS OCCURRED EITHER IMMEDIATELY OR WITHIN APPROXIMATELY 24 HOURS OF TREATMENT; THE PRECISE ONSET TIMING FOR THIS PATIENT IS UNKNOWN. THE PROCEDURE WAS PERFORMED USING A CLOSED-END, SIDE-VENTED 30-GAUGE IRRIGATION TIP, AND NO PROCEDURAL DEVIATIONS WERE NOTED. CLINICAL FINDINGS WERE CONSISTENT WITH A SODIUM HYPOCHLORITE EXTRAVASATION EVENT. THE PATIENT WAS TREATED WITH STEROIDS AND ANTIBIOTICS AND FULLY RECOVERED WITHOUT PERMANENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90247 CHLOR-XTRA SODIUM HYPOCHLORITE SOLUTION KJJ INTER-MED, INC. 2025-1997 20818207020479

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female Required Intervention