BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULAB SYSTEMS DENTAL ALIGNER

    MDR report key: 22647403 · Received July 29, 2025

    Report

    Report Number
    3017155477-2025-00019
    Event Type
    Injury
    Date Received
    July 29, 2025
    Date of Event
    July 14, 2025
    Report Date
    July 29, 2025
    Manufacturer
    ULAB SYSTEMS
    Product Code
    NXC
    UDI-DI
    00860002380094
    PMA / PMN Number
    K192596
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHO: THE DOCTOR CONTACTED ULAB REGARDING A POSSIBLE ALLERGY TO REVA MATERIAL. WHAT: PATIENT EXPERIENCED LIP AND THROAT SWELLING. WHEN: (B)(6) 2025. WHERE: ALIGNERS WERE IN THE PATIENT'S POSSESSION. WHY: NO RMA SIX PIECES (L11B, U01B, U02B, U04B, U06B, U11B) REJECTED FOR MISALIGNED TRIM ON (B)(6) 2025. INSPECTED AT QA03 BY #195 ON 5/29/2025. PER DISCUSSION IN THE COMPLAINT MEETING ON (B)(6) 2025, , REQUESTING MORE INFORMATION FROM THE DOCTOR REGARDING KNOWN ALLERGIES, DID THE SYMPTOMS STOP ONCE THEY DISCONTINUED WEARING THE ALIGNERS, IS THE PATIENT SEEKING MEDICAL ATTENTION? 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 (B)(6) 2025.

    Description of Event or Problem · 0

    WHO: THE DOCTOR CONTACTED ULAB REGARDING A POSSIBLE ALLERGY TO REVA MATERIAL. WHAT: PATIENT EXPERIENCED LIP AND THROAT SWELLING. WHEN: (B)(6) 2025. WHERE: ALIGNERS WERE IN THE PATIENT'S POSSESSION. WHY: NO RMA SIX PIECES (L11B, U01B, U02B, U04B, U06B, U11B) REJECTED FOR MISALIGNED TRIM ON (B)(6) 2025. INSPECTED AT QA03 BY #195 ON 5/29/2025. PER DISCUSSION IN THE COMPLAINT MEETING ON (B)(6) 2025, REQUESTING MORE INFORMATION FROM THE DOCTOR REGARDING KNOWN ALLERGIES, DID THE SYMPTOMS STOP ONCE THEY DISCONTINUED WEARING THE ALIGNERS, IS THE PATIENT SEEKING MEDICAL ATTENTION? 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 (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1087022 ULAB SYSTEMS DENTAL ALIGNER FG0094, ULAB SYSTEMS ALIGNER KIT NXC ULAB SYSTEMS FG0094 SOJ16 00860002380094

    Patients

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