BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITERO ELEMENT 2

    MDR report key: 19495255 · Received June 9, 2024

    Report

    Report Number
    3009646999-2024-01565
    Event Type
    Injury
    Date Received
    June 9, 2024
    Date of Event
    May 17, 2024
    Report Date
    November 26, 2024
    Manufacturer
    ALIGN TECHNOLOGY, LTD.
    Product Code
    NOF
    UDI-DI
    00816063020288
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION ABOUT THE USER'S CONDITION WAS OBTAINED DESPITE ATTEMPTS TO GATHER THIS INFORMATION, NOR WAS THE DEVICE RETURNED FOR FURTHER INVESTIGATION. THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF AVAILABLE PHOTOGRAPHS AND INFORMATION SUPPLIED BY THE USER. ALIGN'S CLINICAL ASSESSMENT OF THE AVAILABLE RECORDS INDICATE THAT THE USER'S HAND INJURY WAS A MINOR, SUPERFICIAL INJURY THAT DID NOT POSE ANY IMMEDIATE RISK TO LIFE, NOR DID IT SUGGEST THE PRESENCE OF SIGNIFICANT TRAUMA LIKELY TO RESULT IN PERMANENT IMPAIRMENT OR DISABILITY. WITH THIS, ALIGN CONCLUDES THAT THE USER SOUGHT HOSPITAL CARE AS A PRECAUTIONARY MEASURE.

    Additional Manufacturer Narrative · 0

    UPDATES WERE MADE AFTER REVIEWING THE QUALITY OF DEVICE IDENTIFICATION INFORMATION SUBMITTED PREVIOUSLY AGAINST DATA IN THE GUDID.

    Additional Manufacturer Narrative · 0

    THE CURRENT USER MANUAL FOR THE ITERO ELEMENT 2 IMAGING SYSTEM CONTAINS THE FOLLOWING ELECTRIC WARNINGS: "DO NOT CONNECT THE SCANNER TO A MAINS SUPPLY WITHOUT PROTECTIVE GROUNDING, IN ORDER TO AVOID THE RISK OF ELECTRICAL SHOCK". THIS EVENT IS BEING FILED AS AN MDR AS THE USER EXPERIENCED A MINOR INJURY ON HAND, REQUIRING VISITING THE EMERGENCY ROOM, AND THE ALIGN TECHNOLOGY, LTD. MEDICAL DEVICE WAS BEING USED. INVESTIGATION OF THIS EVENT IS CURRENTLY ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    COMPLAINANT REPORTED THAT A USER OF AN ITERO ELEMENT 2 SYSTEM EXPERIENCED A MINOR BURN ON HAND WHEN PLUGGING THE CABLE INTO AN OUTLET. THE USER REQUIRED GOING TO THE EMERGENCY ROOM TO ADDRESS THE REPORTED SYMPTOMS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2319063 ITERO ELEMENT 2 SYSTEM, OPTICAL IMPRESSION, COMPUTER ASSISTED DESIGN AND MANUFACTURING (CAD/CAM) NOF ALIGN TECHNOLOGY, LTD. 202965 00816063020288

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other