MAUDE Adverse Event Report: ALLIANCE PHARMA INC. CANKER-X RINCINOL MOUTH SORE RINSE

Lot Number	045552
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Burning Sensation (2146); Glossitis (4490)
Date of Event	06/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: CANKER-X RINCINOL MOUTH SORE RINSE
• Common Device Name: CANKER-X
• Manufacturer (Section D): ALLIANCE PHARMA INC.; 11000 regency parkway; ste. 106; cary NC 27518
• Manufacturer Contact: anna skylar ; 11000 regency parkway; ste 106; cary, NC 27518 ; 4242900495
• MDR Report Key: 24778301
• Report Number: 3019867040-2026-00001
• Device Sequence Number: 9888834
• Product Code: OLR
• UDI-Device Identifier: 00358962302008
• UDI-Public: 00358962302008
• Combination Product (Y/N): N
• PMA/510(K) Number: K023155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Lot Number: 045552
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "MAGIC MOUTHWASH WITH LIDOCAINE"; ACYCLOVIR; EPINEPHRINE IV; NYSTATIN; UNSPECIFIED CHOLESTEROL MEDICATION; UNSPECIFIED EYE VITAMINS
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female