BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANKER-X RINCINOL MOUTH SORE RINSE

    MDR report key: 24778301 · Received April 3, 2026

    Report

    Report Number
    3019867040-2026-00001
    Event Type
    Injury
    Date Received
    April 3, 2026
    Report Date
    January 4, 2026
    Manufacturer
    ALLIANCE PHARMA INC.
    Product Code
    OLR
    UDI-DI
    00358962302008
    PMA / PMN Number
    K023155
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH RECORDS REVIEW FOR THE LOT IN QUESTION WAS CONDUCTED. NO DEVIATIONS, ATYPICAL FINDINGS, OOS RESULTS, OR ANOMALIES WERE FOUND. THE LOT MET ALL MANUFACTURING AND RELEASE SPECIFICATIONS. THE COMPANY'S SAFETY PHYSICIAN EVALUATED INFORMATION FROM THE INITIAL REPORTER (USER). GIVEN THE TEMPORAL RELATIONSHIP AND THE ABSENCE OF AN ALTERNATIVE CONFIRMED DIAGNOSIS, CAUSALITY ASSESSED AS POSSIBLE.

    Description of Event or Problem · 0

    A 72-YEAR-OLD CONSUMER REPORTED A SEVERE ORAL ADVERSE REACTION FOLLOWING A SINGLE USE OF CANKER-X RINCINOL MOUTH SORE RINSE. THE CONSUMER STATED THEY FOLLOWED THE INSTRUCTIONS TO SWISH FOR ONE MINUTE AND SPIT. IMMEDIATELY UPON USE, THE CONSUMER EXPERIENCED INTENSE BURNING OF THE TONGUE, GUMS, AND ORAL MUCOSA, WITH ASSOCIATED TOOTH PAIN AND DIFFICULTY SPEAKING. THE CONSUMER DESCRIBED THE ONSET AS INSTANTANEOUS AND CLEARLY LINKED IT TO PRODUCT USE. SYMPTOMS PERSISTED THROUGHOUT THE FOLLOWING 2-3 WEEKS. THE CONSUMER REPORTED SIGNIFICANT FUNCTIONAL LIMITATIONS, INCLUDING PAIN WITH SPEAKING, CHEWING, AND SWALLOWING, AND WAS ABLE TO TOLERATE ONLY SOFT FOODS SUCH AS OATMEAL AND SOUP. THE BURNING SENSATION WAS REPORTED TO BE UNCHANGED DESPITE RINSING WITH WATER AND USING PRESCRIBED TREATMENTS. THE CONSUMER SOUGHT REPEATED MEDICAL EVALUATION, INCLUDING MULTIPLE EMERGENCY DEPARTMENT VISITS, AN AMBULANCE TRANSPORT FOR TONGUE SWELLING AND DIFFICULTY SWALLOWING, AND EVALUATIONS BY AN INFECTIOUS DISEASE SPECIALIST, AN ORAL AND MAXILLOFACIAL SURGEON, AND OTHER PHYSICIANS. ACCORDING TO THE CONSUMER, EXTENSIVE LABORATORY TESTING WAS PERFORMED TO INVESTIGATE POTENTIAL INFECTIOUS, INFLAMMATORY, AUTOIMMUNE, OR SYSTEMIC CAUSES. REPORTED TESTS INCLUDED HIV, MONONUCLEOSIS, HEPATITIS PANEL, SEXUALLY TRANSMITTED INFECTION PANEL, AND OTHER BLOODWORK EXCEEDING 40 TESTS, ALL OF WHICH WERE REPORTEDLY NEGATIVE. A BIOPSY OF A CANKER SORE REPORTEDLY SHOWED BENIGN FINDINGS. A COVID19 TEST WAS ALSO REPORTEDLY NEGATIVE. THE CONSUMER REPORTED NO UNDERLYING MEDICAL CONDITIONS OTHER THAN STABLE, ROUTINE MAINTENANCE MEDICATIONS SUCH AS A CHOLESTEROL DRUG AND EYE VITAMINS. THE CONSUMER DENIED SMOKING, ALCOHOL USE, RECENT EXPOSURES, OR USE OF NEW TOOTHPASTE OR MOUTHWASH. THE CONSUMER REPORTED BEING GENERALLY HEALTHY AND ACTIVE. DURING A LATER EMERGENCY DEPARTMENT VISIT, THE CONSUMER REPORTED THAT TONGUE SWELLING AND DIFFICULTY SWALLOWING HER OWN SALIVA LED TO ADMINISTRATION OF IV EPINEPHRINE FOR A PRESUMED ALLERGIC REACTION. THE CONSUMER REPORTED THAT TREATING PHYSICIANS INDICATED THIS REACTION COULD THEORETICALLY OCCUR ON A DELAYED BASIS IF AN ALLERGIC MECHANISM WERE INVOLVED, THOUGH NO FORMAL DIAGNOSIS WAS COMMUNICATED TO THE MANUFACTURER. THE CONSUMER DENIED PRIOR SIMILAR REACTIONS AND DENIED CONCURRENT MEDICATION OR PRODUCT USE THAT COULD EXPLAIN THE EVENT. SYMPTOMS OF BURNING ORAL PAIN WERE STILL ONGOING AT THE TIME OF THEIR LATEST COMMUNICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29653 CANKER-X RINCINOL MOUTH SORE RINSE CANKER-X OLR ALLIANCE PHARMA INC. 045552 00358962302008

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Hospitalization "MAGIC MOUTHWASH WITH LIDOCAINE"| ACYCLOVIR| EPINEPHRINE IV| NYSTATIN| UNSPECIFIED CHOLESTEROL MEDICATION| UNSPECIFIED EYE VITAMINS