BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULAB SYSTEMS USMILE ALIGNER

    MDR report key: 19274317 · Received May 8, 2024

    Report

    Report Number
    3017155477-2024-00009
    Event Type
    Injury
    Date Received
    May 8, 2024
    Date of Event
    April 14, 2024
    Report Date
    May 8, 2024
    Manufacturer
    ULAB SYSTEMS
    Product Code
    NXC
    UDI-DI
    00860002380094
    PMA / PMN Number
    K192596
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHO: THE DOCTOR CONTACTED ULAB REGARDING A POSSIBLE ALLERGIC REACTION TO ALIGNERS. WHAT: THE PATIENT EXPERIENCED A POSSIBLE ALLERGIC REACTION TO ALIGNERS AFTER FEW WEEKS OF USE. WHEN: 4/12/2024 WHERE: THE ALIGNERS WERE IN THE PATIENT'S POSSESSION AT THE TIME OF THE ALLERGIC REACTION. WHY: THE PATIENT HAD A PRIOR POSSIBLE ALLERGIC REACTION TO PREVIOUS ALIGNERS (JRN10). THERE HAS BEEN NO ADDITIONAL INFORMATION REGARDING THE PATIENT'S ALLERGY HISTORY, ETC, PROVIDED BY THE DOCTOR. NO RMA ISSUED. THERE WAS NO MANUFACTURING DEFECTS DETECTED. THE CAUSE OF THE PATIENT'S REACTION REMAINS UNDETERMINED. IT IS NOT KNOWN IF THE ALIGNER USED DURING THE TREATMENT (ADHESIVES/ATTACHMENT BONDING/LATEX) CAUSED THE PATIENT'S ALLERGIC REACTION. AS WE DON'T HAVE ANY INFORMATION ON THE PATIENT'S ALLERGY HISTORY, THIS REACTION MAY BE DUE TO OTHER EXTERNAL FACTORS/COMMON ALLERGENS THAT WERE INTRODUCTED COINCIDENTALLY AT THE TIME OF THE PLACEMENT OF THE ALIGNERS, SUCH AS POLLENS, DUST MITES, PET ALLERGENS, BIOLOGIC PRODUCTS, INSECT VENOMS. CONCLUSION: THE CAUSE OF THE POSSIBLE ALLERGIC REACTION IS UNDETERMINED. ULAB SYSTEMS REPORTED THIS MINOR ALLERGIC REACTION AS AN EMDR THROUGH OUR WEB TRADER PRODUCTION ACCOUNT ON 5/8/2024. PER SOP0014, MANDATORY MEDICAL DEVICE REPORTING, SECTION 8 (AUSTRALIA), THIS ALLERGIC REACTION INCIDENT IS NOT SIGNIFICANT ENOUGH FOR THE AUSTRALIA REPORTABILITY CRITERIA AND WILL NOT BE REPORTED AS AN ADVERSE INCIDENT TO THE ULAB AUSTRALIAN SPONSOR (EMERGO) OR THE RELEVANT AUSTRALIAN REGULATORY AUTHORITY, PER THE REPORTING REQUIREMENTS/TIMELINES AND AUSTRALIAN MEDICAL DEVICES GUIDELINES (ARGMD), CHAPTER 22 POST-MARKET VIGILANCE AND MONITORING REQUIREMENTS.

    Description of Event or Problem · 0

    WHO: THE DOCTOR CONTACTED ULAB REGARDING A POSSIBLE ALLERGIC REACTION TO ALIGNERS. WHAT: THE PATIENT EXPERIENCED A POSSIBLE ALLERGIC REACTION TO ALIGNERS AFTER FEW WEEKS OF USE. WHEN: 4/12/2024 WHERE: THE ALIGNERS WERE IN THE PATIENT'S POSSESSION AT THE TIME OF THE ALLERGIC REACTION. WHY: THE PATIENT HAD A PRIOR POSSIBLE ALLERGIC REACTION TO PREVIOUS ALIGNERS (JRN10). THERE HAS BEEN NO ADDITIONAL INFORMATION REGARDING THE PATIENT'S ALLERGY HISTORY, ETC, PROVIDED BY THE DOCTOR. NO RMA ISSUED. THERE WAS NO MANUFACTURING DEFECTS DETECTED. THE CAUSE OF THE PATIENT'S REACTION REMAINS UNDETERMINED. IT IS NOT KNOWN IF THE ALIGNER USED DURING THE TREATMENT (ADHESIVES/ATTACHMENT BONDING/LATEX) CAUSED THE PATIENT'S ALLERGIC REACTION. AS WE DON'T HAVE ANY INFORMATION ON THE PATIENT'S ALLERGY HISTORY, THIS REACTION MAY BE DUE TO OTHER EXTERNAL FACTORS/COMMON ALLERGENS THAT WERE INTRODUCTED COINCIDENTALLY AT THE TIME OF THE PLACEMENT OF THE ALIGNERS, SUCH AS POLLENS, DUST MITES, PET ALLERGENS, BIOLOGIC PRODUCTS, INSECT VENOMS. CONCLUSION: THE CAUSE OF THE POSSIBLE ALLERGIC REACTION IS UNDETERMINED. ULAB SYSTEMS REPORTED THIS MINOR ALLERGIC REACTION AS AN EMDR THROUGH OUR WEB TRADER PRODUCTION ACCOUNT ON 5/8/2024. PER SOP0014, MANDATORY MEDICAL DEVICE REPORTING, SECTION 8 (AUSTRALIA), THIS ALLERGIC REACTION INCIDENT IS NOT SIGNIFICANT ENOUGH FOR THE AUSTRALIA REPORTABILITY CRITERIA AND WILL NOT BE REPORTED AS AN ADVERSE INCIDENT TO THE ULAB AUSTRALIAN SPONSOR (EMERGO) OR THE RELEVANT AUSTRALIAN REGULATORY AUTHORITY, PER THE REPORTING REQUIREMENTS/TIMELINES AND AUSTRALIAN MEDICAL DEVICES GUIDELINES (ARGMD), CHAPTER 22 POST-MARKET VIGILANCE AND MONITORING REQUIREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141618 ULAB SYSTEMS USMILE ALIGNER CLEAR ALIGNER NXC ULAB SYSTEMS FG0094 00860002380094

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other FG0094 - ULAB SYSTEMS USMILE DENTAL ALIGNER KIT