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

Model Number INVISALIGN CLEANING CRYSTALS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Nausea (1970)

Event Date 09/18/2023

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 325443770
• Report Number: 2953749-2023-02897
• Device Sequence Number: 1
• Product Code: EFT
• UDI-Device Identifier: 00816063021407
• UDI-Public: (01)00816063021407
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 42 YR
• Patient Sex: Male