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U.S. Department of Health and Human Services

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

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ALIGN TECHNOLOGY, INC. INVISALIGN CLEANING CRYSTALS; CLEANSER, DENTURE, OVER THE COUNTER Back to Search Results
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.
 
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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 Key17916537
MDR Text Key325443770
Report Number2953749-2023-02897
Device Sequence Number1
Product Code EFT
UDI-Device Identifier00816063021407
UDI-Public(01)00816063021407
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
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 NumberINVISALIGN CLEANING CRYSTALS
Device Catalogue Number20127
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/19/2023
Initial Date FDA Received10/11/2023
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 Number1
Patient Outcome(s) Hospitalization;
Patient Age42 YR
Patient SexMale
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