MAUDE Adverse Event Report: GC AMERICA INC. MI PASTE PLUS MINT TOPICAL PASTE WITH BIO-AVAILABLE; AGENT, POLISHING, ABRASIVE, ORAL CAVITY

Model Number	422621
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	09/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Although it cannot be conclusively determined that the symptoms were directly attributable to mi paste plus mint, the product remains a possible contributing factor.Given the physician's assessment that the patient was heading toward an anaphylactic reaction, the event presents the potential for serious injury if it were to recur.Therefore, based on the serious nature of the reaction, the possible causal relationship to the product, and in accordance with 21 cfr 803.3(o)(2) stated as follows: (1) an event that user facilities become aware of that reasonably suggests that a device has or may have caused or contributed to a death or serious injury or (2) an event that manufacturers or importers become aware of that reasonably suggests that one of their marketed devices: (i) may have caused or contributed to a death or serious injury, or (ii) has malfunctioned and that the device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.This adverse event is determined to be reportable.Even though an allergic reaction may be an expected symptom especially for patients with milk protein allergy or mint flavoring, the seriousness, and not the expectedness, requires the event to still be reportable.(b)(6), (b)(6) 2025.

• Brand Name: MI PASTE PLUS MINT TOPICAL PASTE WITH BIO-AVAILABLE
• Common Device Name: AGENT, POLISHING, ABRASIVE, ORAL CAVITY
• Manufacturer (Section D): GC AMERICA INC.; alsip IL 60803
• MDR Report Key: 23109342
• Report Number: MW5176278
• Device Sequence Number: 9243043
• Product Code: EJR
• UDI-Device Identifier: D6584226211
• UDI-Public: D6584226211
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2025

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: Health Professional
• Device Expiration Date: 07/21/2025
• Device Model Number: 422621
• Device Lot Number: 250120J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female