BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULAB SYSTEMS DENTAL ALIGNER

    MDR report key: 19366879 · Received May 21, 2024

    Report

    Report Number
    3017155477-2024-00010
    Event Type
    Injury
    Date Received
    May 21, 2024
    Date of Event
    May 1, 2024
    Report Date
    May 1, 2024
    Manufacturer
    ULAB SYSTEMS
    Product Code
    NXC
    UDI-DI
    00860002380094
    PMA / PMN Number
    K192596
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHO: THE DOCTOR CONTACTED ULAB REGARDING A POSSIBLE ALLERGIC REACTION. WHAT: DR. (B)(6) WANTED TO KNOW WHAT IS USED TO CLEAN ALIGNERS AFTER MANUFACTURING THEM. PATIENT POSSIBLY HAVING AN ALLERGIC REACTION TO CLEANER. WHEN: (B)(6) 2024. WHERE: CHAIRSIDE WHILE DELIVERING THE ALIGNERS TO THE PATIENT. WHY: NO RMA ISSUED. NO MANUFACTURING DEFECTS. EMAILED DR. (B)(6) THE SDS ON LIQUINOX. WAITING ON FURTHER INFORMATION AFTER HE RECEIVES EMAIL AND SPEAKS MORE WITH PATIENT. PER DISCUSSION IN THE COMPLAINT MEETING ON 5/2/2024, THE CAUSE OF THE PATIENT'S REACTION REMAINS UNDETERMINED. IT IS NOT KNOWN IF THE ALIGNER MATERIAL OR OTHER MATERIALS 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 INTRODUCED COINCIDENTALLY AT SAME TIME AS THE PLACEMENT OF THE ALIGNERS, SUCH AS POLLENS, DUSTMITES, PET ALLERGENS, BIOLOGIC PRODUCTS, INSECT VENOMS. CONCLUSION: THE CAUSE OF THE POSSIBLE ALLERGIC REACTION IS UNDETERMINED. UPON REQUEST FOR FURTHER INFORMATION, THE DOCTOR RESPONDED THAT THE PARTS WERE CLEANED WITH ANTI-BACTERIAL SOAP AND MOUTHWASH, AND THE PATIENT HAD NO FURTHER ISSUES. ULAB SYSTEMS REPORTED THIS MINOR ALLERGIC REACTION AS AN EMDR THROUGH OUR WEBTRADER PRODUCTION ACCOUNT, ON 05/21/2024.

    Description of Event or Problem · 0

    WHAT: DR. (B)(6) WANTED TO KNOW WHAT IS USED TO CLEAN ALIGNERS AFTER MANUFACTURING THEM. PATIENT POSSIBLY HAVING AN ALLERGIC REACTION TO CLEANER. WHEN: (B)(6) 2024. WHERE: CHAIRSIDE WHILE DELIVERING THE ALIGNERS TO THE PATIENT. WHY: NO RMA ISSUED NO MANUFACTURING DEFECTS EMAILED DR. (B)(6) THE SDS ON LIQUINOX. WAITING ON FURTHER INFORMATION AFTER HE RECEIVES EMAIL AND SPEAKS MORE WITH PATIENT. PER DISCUSSION IN THE COMPLAINT MEETING ON 5/2/2024, THE CAUSE OF THE PATIENT'S REACTION REMAINS UNDETERMINED. IT IS NOT KNOWN IF THE ALIGNER MATERIAL OR OTHER MATERIALS 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 INTRODUCED COINCIDENTALLY AT SAME TIME AS THE PLACEMENT OF THE ALIGNERS, SUCH AS POLLENS, DUSTMITES, PET ALLERGENS, BIOLOGIC PRODUCTS, INSECT VENOMS. CONCLUSION: THE CAUSE OF THE POSSIBLE ALLERGIC REACTION IS UNDETERMINED. UPON REQUEST FOR FURTHER INFORMATION, THE DOCTOR RESPONDED THAT AFTER CLEANING THE PARTS WITH ANTI-BACTERIAL SOAP AND MOUTHWASH, THE PATIENT HAD NO FURTHER ISSUES. ULAB SYSTEMS REPORTED THIS MINOR ALLERGIC REACTION AS AN EMDR THROUGH OUR WEBTRADER PRODUCTION ACCOUNT, ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603185 ULAB SYSTEMS DENTAL ALIGNER CLEAR ALIGNER NXC ULAB SYSTEMS FG0094 00860002380094

    Patients

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