MAUDE Adverse Event Report: ALIGN TECHNOLOGY, INC. INVISALIGN CLEANING CRYSTALS; CLEANSER, DENTURE, OVER THE COUNTER

Model Number	20127
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burning Sensation (2146); Numbness (2415); Aphonia (4409)
Date of Event	02/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The current indications for use (ifu) contains the following: "warnings - do not place crystals in mouth or ingest.In case of accidental ingestion, immediately contact a poison-control center.".No conclusive evidence has been provided that supports or opposes whether the cleaning crystals, packette caused or contributed to the required hospitalization (initial or prolonged) and the cleaning crystals, packette were being used.Therefore, an mdr will be filed in the united states per 21 cfr 803.
Event or Problem Description
The treated patient reported persistent difficulty closing the mouth, numbness, tingling, and burning in the mouth after using the cleaning crystals, that have impacted the ability to speak, eat swallow and weight loss that required hospitalization for 4 days on (b)(6).These symptoms do not appear to be life threatening to the patient.The patient indicated that during the hospitalization, required different medications (not clarified how many or which ones) to alleviate the reported symptom(s).No additional information is available at this time.
Additional Manufacturer Narrative
Information was edited: the brand name and labeled for use were modified.

• Brand Name: INVISALIGN CLEANING CRYSTALS
• Common Device Name: CLEANSER, DENTURE, OVER THE COUNTER
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.; 2820 orchard parkway; san jose CA 95134
• Manufacturer (Section G): ALIGN TECHNOLOGY, INC.; 2820 orchard parkway; san jose CA 95134
• Manufacturer Contact: janier duarte santana ; 2820 orchard parkway; san jose, CA 95134
• MDR Report Key: 21740625
• Report Number: 2953749-2025-00621
• Device Sequence Number: 14448350
• Product Code: EFT
• UDI-Device Identifier: 00816063021407
• UDI-Public: (01)00816063021407
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2025

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: Lay User/Patient
• Device Model Number: 20127
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 04/03/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 19 YR
• Patient Sex: Female