BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULAB SYSTEMS DENTAL ALIGNER

    MDR report key: 22575236 · Received July 23, 2025

    Report

    Report Number
    3017155477-2025-00017
    Event Type
    Injury
    Date Received
    July 23, 2025
    Date of Event
    June 23, 2025
    Report Date
    July 17, 2025
    Manufacturer
    ULAB SYSTEMS
    Product Code
    NXC
    UDI-DI
    00860002380094
    PMA / PMN Number
    K192596
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHO: THE DOCTOR CONTACTED ULAB REGARDING A POSSIBLE ALLERGIC REACTION. WHAT: PATIENT EXPERIENCED HEADACHE AND NAUSEA ALONG WITH SINUS ISSUES. WHEN: (B)(6) 2025. WHERE: ALIGNERS WERE IN THE PATIENT'S POSSESSION AT THE TIME OF THE POSSIBLE ALLERGIC REACTION. WHY: NO RMA. NO MANUFACTURING DEFECTS. INSPECTED AT QA03 ON 5/16/2025 BY #241. PER DISCUSSION IN THE COMPLAINT MEETING ON 6/24/2025, REQUESTING MORE INFORMATION FROM THE DOCTOR REGARDING KNOWN ALLERGIES, DID THEY SEEK MEDICAL ATTENTION, DID THE SYMPTOMS STOP ONCE THEY DISCONTINUED WEARING THE ALIGNERS? CONCLUSION: THIS COMPLAINT WILL CLOSE AS UNDETERMINED. THIS REACTION MAY BE DUE TO OTHER EXTERNAL FACTORS/COMMON ALLERGENS THAT WERE INTRODUCED COINCIDENTALLY AT SAME TIME AS THE PLACEMENT OF THE ALIGNERS, SUCH AS POLLENS, DUSTMITES, PET ALLERGENS, BIOLOGIC PRODUCTS, INSECT VENOMS. THE CAUSE OF THE POSSIBLE ALLERGIC REACTION IS UNDETERMINED. THE DOCTOR PROVIDED THE SYMPTOMS THE PATIENT DISPLAYED BUT NO FURTHER INFORMATION. THE PRODUCT WAS NOT RETURNED. ULAB SYSTEMS REPORTED THIS MINOR ALLERGIC REACTION AS AN EMDR THROUGH OUR WEBTRADER PRODUCTION ACCOUNT, ON 07/17/2025.

    Description of Event or Problem · 0

    WHO: THE DOCTOR CONTACTED ULAB REGARDING A POSSIBLE ALLERGIC REACTION. WHAT: PATIENT EXPERIENCED HEADACHE AND NAUSEA ALONG WITH SINUS ISSUES. WHEN: (B)(6) 2025. WHERE: ALIGNERS WERE IN THE PATIENT'S POSSESSION AT THE TIME OF THE POSSIBLE ALLERGIC REACTION. WHY: NO RMA. NO MANUFACTURING DEFECTS. INSPECTED AT QA03 ON 5/16/2025 BY #241. PER DISCUSSION IN THE COMPLAINT MEETING ON 6/24/2025, REQUESTING MORE INFORMATION FROM THE DOCTOR REGARDING KNOWN ALLERGIES, DID THEY SEEK MEDICAL ATTENTION, DID THE SYMPTOMS STOP ONCE THEY DISCONTINUED WEARING THE ALIGNERS? PER OFFICE: CAN'T BREATHE AND FACE AND LIPS SWOLLEN. NO KNOWN ALLERGIES. NO ALLERGY TEST PLANNED. TRY A DIFFERENT ALIGNER COMPANY OR PUT HIM IN BRACES. HAD RESTORATIVE WORK. HE WANTS TO SWITCH TO INVISALIGN FROM ANOTHER PROVIDER. WEARING PART TIME. MAYBE STOPPED OVER THE WEEKEND. TRY A DIFFERENT MATERIAL. CONCLUSION: THIS COMPLAINT WILL CLOSE AS UNDETERMINED. THIS REACTION MAY BE DUE TO OTHER EXTERNAL FACTORS/COMMON ALLERGENS THAT WERE INTRODUCED COINCIDENTALLY AT SAME TIME AS THE PLACEMENT OF THE ALIGNERS, SUCH AS POLLENS, DUSTMITES, PET ALLERGENS, BIOLOGIC PRODUCTS, INSECT VENOMS. THE CAUSE OF THE POSSIBLE ALLERGIC REACTION IS UNDETERMINED. THE DOCTOR PROVIDED THE SYMPTOMS THE PATIENT DISPLAYED BUT NO FURTHER INFORMATION. THE PRODUCT WAS NOT RETURNED. ULAB SYSTEMS REPORTED THIS MINOR ALLERGIC REACTION AS AN EMDR THROUGH OUR WEBTRADER PRODUCTION ACCOUNT, ON 07/17/2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1869855 ULAB SYSTEMS DENTAL ALIGNER FG0094, ULAB SYSTEMS SLIGNER KIT NXC ULAB SYSTEMS FG0094 HLH16 00860002380094

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other FG0094, ULAB SYSTEMS USMILE ALIGNER KIT