BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULAB SYSTEMS USMILE ALIGNER

    MDR report key: 18023101 · Received October 27, 2023

    Report

    Report Number
    3017155477-2023-00007
    Event Type
    Injury
    Date Received
    October 27, 2023
    Date of Event
    October 12, 2023
    Report Date
    October 27, 2023
    Manufacturer
    ULAB SYSTEMS
    Product Code
    NXC
    UDI-DI
    00860002380094
    PMA / PMN Number
    K192596N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CAUSE OF THE PATIENT'S ALLERGIC REACTION IS UNDETERMINED. IT IS UNKNOWN IF THE ALIGNER MATERIAL WAS THE CAUSE OF THE ALLERGIC REACTION, IF IT WAS A VIRAL INFECTION THAT RAN ITS COURSE, OR IF OTHER EXTERNAL FACTORS / COMMON ALLERGENS WERE INTRODUCED AT SAME TIME AS THE ALIGNER TREATMENT, SUCH AS POLLENS, DUST-MITES, PET ALLERGENS, BIOLOGIC PRODUCTS, INSECT VENOMS, OR OTHER ORTHODONTIC TREATMENT MATERIALS INCLUDING GLUES/ADHESIVES, RUBBER BANDS, LATEX, OR ATTACHMENT MATERIALS USED IN THE TREATMENT PLANNING. ADDITIONALLY, THE DOCTOR STATED THAT THE PATIENT IS ALLERGIC TO SULFA DRUGS WHICH ARE COMMONLY USED TO TREAT BACTERIAL INFECTIONS. THE DOCTOR STATED THAT THE PATIENT HAD A REACTION WITH 2 ALIGNERS IN THE 1ST REFINEMENT AND 1 ALIGNER IN THE 2ND REFINEMENT, WHICH RESULTED IN SWELLING FOR ABOUT 3-4 WEEKS. THE DOCTOR ALSO STATED "I'M NOT SURE IT WAS AN ALLERGY, BECAUSE IT WAS ONLY 1 ALIGNER. I HAD AN INVISALIGN PATIENT THAT HAD A POLYESTER ALLERGY, THAT COULD NOT TOLERATE ANY ALIGNERS. THIS WAS LIP SWELLING THAT IMO, VIRAL AND IT RAN IT'S COURSE". PER SOP0014, MANDATORY MEDICAL DEVICE REPORTING ULAB SYSTEMS REPORTED THIS ALLERGIC REACTION AS AN EMDR (FORM FDA 3500A) THROUGH OUR WEBTRADER PRODUCTION ACCOUNT, ON 10/27/2023. REFER TO THE ATTACHED MEDWATCH FDA ESUBMITTER GENERATED FORM 3500A- MFR REPORT #: 3017155477-2023-00007.

    Description of Event or Problem · 0

    ON (B)(6) 2023, THE DOCTORS OFFICE INFORMED ULAB SYSTEMS' CLIENT SERVICES GROUP THAT THEIR PATIENT HAD A POTENTIAL ALLERGIC REACTION DURING THEIR TREATMENT TO A USMILE ALIGNER. WHY: NO RMA ISSUED. CLIENT SERVICES REPLIED VIA EMAIL TO THE DOCTOR'S OFFICE AND PROVIDED THE MSDS SHEET FOR THE ALIGNER MATERIAL WHICH IS USED TO MANUFACTURER THE USMILE ALIGNERS. CLIENT SERVICES ALSO ASKED THE DOCTOR IF THE PATIENT HAD ANY KNOWN ALLERGIES, AND THE DOCTOR RESPONDED THAT THE PATIENT IS ALLERGIC TO SULFA DRUGS (CO-TRIMOXAZOLE (SEPTRIN), SULFADIAZINE, SULFAMETHOXAZOLE (GANTANOL), TRIMETHOPRIM-SULFAMETHOXAZOLE (BACTRIM, BACTRIM DS, SEPTRA, AND SEPTRA DS), TRIMETHOPRIM (TRIMPEX, PROLOPRIM, AND PRIMSOL), SULFASALAZINE (AZULFIDINE EN-TABS, AZULFIDINE, AND SULFAZINE), SULFISOXAZOLE (GANTRISIN)) WHICH ARE COMMONLY USED TO TREAT BACTERIAL INFECTIONS. THE DOCTOR STATED THAT THE PATIENT HAD A REACTION WITH 2 ALIGNERS IN THE 1ST REFINEMENT AND 1 ALIGNER IN THE 2ND REFINEMENT, WHICH RESULTED IN SWELLING FOR ABOUT 3-4 WEEKS. THE DOCTOR ALSO STATED "I'M NOT SURE IT WAS AN ALLERGY, BECAUSE IT WAS ONLY 1 ALIGNER. I HAD AN INVISALIGN PATIENT THAT HAD A POLYESTER ALLERGY, THAT COULD NOT TOLERATE ANY ALIGNERS. THIS WAS LIP SWELLING THAT IMO, VIRAL AND IT RAN IT'S COURSE". CONCLUSION: THE CAUSE OF THE PATIENT'S ALLERGIC REACTION IS UNDETERMINED. IT IS UNKNOWN IF THE REVA MATERIAL WAS THE CAUSE OF THE ALLERGIC REACTION, IF IT WAS A VIRAL INFECTION THAT RAN ITS COURSE, OR IF OTHER EXTERNAL FACTORS / COMMON ALLERGENS WERE INTRODUCED AT SAME TIME AS THE ALIGNER TREATMENT, SUCH AS POLLENS, DUST-MITES, PET ALLERGENS, BIOLOGIC PRODUCTS, INSECT VENOMS, OR OTHER ORTHODONTIC TREATMENT MATERIALS INCLUDING GLUES/ADHESIVES, RUBBER BANDS, LATEX, OR ATTACHMENT MATERIALS USED IN THE TREATMENT PLANNING. PER SOP0014, MANDATORY MEDICAL DEVICE REPORTING ULAB SYSTEMS REPORTED THIS ALLERGIC REACTION AS AN EMDR (FORM FDA 3500A) THROUGH OUR WEBTRADER PRODUCTION ACCOUNT, ON 10/27/2023. REFER TO THE ATTACHED MEDWATCH FDA ESUBMITTER GENERATED FORM 3500A- MFR REPORT #: 3017155477-2023-00007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1960966 ULAB SYSTEMS USMILE ALIGNER CLEAR DENTAL ALIGNER NXC ULAB SYSTEMS FG0094 UJY10 00860002380094

    Patients

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