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

Model Number	INVISALIGN CLEANING CRYSTALS
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Nausea (1970)
Date of Event	09/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported symptoms of nausea and bleeding when coughing due to accidentally ingesting the invisalign cleaning crystals.The patient reported requiring a visit to the emergency room and was admitted for 1 night to alleviate the reported symptoms.The patient reported being prescribed omeprazole and alkaline serum to alleviate the reported symptoms.The patient reported discontinuing the use of the aligners on (b)(6) 2023 and is currently asymptomatic.
Additional Manufacturer Narrative
The current instructions 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." the potential root cause of this event is related back to the accidental ingestion of the invisalign cleaning crystals from the aligners.The patient reported being hospitalized (admitted for 1 night) and the invisalign cleaning crystals were being used, and therefore, this mdr is being filed.

• 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: harper shore ; 3030 slater rd; morrisville, NC 27560 ; 4084701343
• MDR Report Key: 17916537
• Report Number: 2953749-2023-02897
• Device Sequence Number: 2810570
• Product Code: EFT
• UDI-Device Identifier: 00816063021407
• UDI-Public: (01)00816063021407
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 10/11/2023

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: INVISALIGN CLEANING CRYSTALS
• Device Catalogue Number: 20127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 42 YR
• Patient Sex: Male