BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVISALIGN CLEANING CRYSTALS

    MDR report key: 21767116 · Received April 3, 2025

    Report

    Report Number
    2953749-2025-00650
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    March 1, 2025
    Report Date
    April 3, 2025
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    EFT
    UDI-DI
    00816063021407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CURRENT INDICATIONS FOR USE (IFU) CONTAINS THE FOLLOWING: "ALIGNER/RETAINER CLEANING INSTRUCTIONS - REMOVE ALIGNERS/RETAINERS AND RINSE UNDER TAP WATER. PLACE ALIGNERS/RETAINERS INTO A CLEANING CONTAINER AND FILL WITH 100 ML WARM WATER OR TO FILL MARK ON TUB. ADD ONE PACKET OF CLEANING CRYSTALS. GENTLY SHAKE/AGITATE FOR 20 SECONDS TO DISSOLVE AND DISTRIBUTE CRYSTALS. LET STAND FOR 15 MINUTES. GENTLY SHAKE/AGITATE AGAIN FOR 20 SECONDS. RINSE ALIGNERS/RETAINERS AND CONTAINER THOROUGHLY WITH WARM WATER." NO CONCLUSIVE EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES WHETHER THE INVISALIGN CLEANING CRYSTALS CAUSED OR CONTRIBUTED TO THE PRODUCT PROBLEM (E,G, DEFECTS/MALFUNCTIONS) AND THE INVISALIGN CLEANING CRYSTALS WERE BEING USED. THEREFORE, AN MDR WILL BE FILED IN THE UNITED STATES PER 21 CFR 803. THERE IS NO CONCLUSIVE EVIDENCE TO CONFIRM THE DATE OF THE REQUIRED TOOTH EXTRACTION, AND THE DATE (B3) IS BASED ON THE TIMELINES REPORTED TO ALIGN AND COMPARED TO THE PATIENT INFORMATION.

    Description of Event or Problem · 0

    THE PATIENT IS CURRENTLY REPORTING AFTER PUTTING THE "CLEANING CRYSTALS" PRODUCT IN A GLASS CUP, AFTER 15 MINUTES WENT TO LIFT THE GLASS TO REMOVE THE RETAINER, THE GLASS CUP EXPLODED, SHATTERING INTO PIECES AND GETTING STUCK IN THE HAND, FACE AND CHEEKS. THE PATIENT SAID HAS USED THE PRODUCT ALREADY AND THE INSTRUCTIONS FOR USE WERE FOLLOWED. THE PATIENT CONFIRMED THAT THE GLASS CUP DID NOT HAVE ANY CRACKS OR DEFECTS AND WAS A REGULAR DRINKING GLASS CUP. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1736237 INVISALIGN CLEANING CRYSTALS CLEANSER, DENTURE, OVER THE COUNTER EFT ALIGN TECHNOLOGY, INC. 20127 00816063021407

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Life Threatening