{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-18", "results": { "skip": 0, "limit": 1, "total": 20 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "MR.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SAN MATEO", "manufacturer_contact_address_1": "1820 GATEWAY DRIVE", "manufacturer_contact_pcity": "86690085", "event_type": "Injury", "report_number": "3017155477-2022-00001", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20220324", "manufacturer_address_2": "", "pma_pmn_number": "K192596", "date_of_event": "20220224", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "94404", "reporter_occupation_code": "DENTIST", "manufacturer_contact_plocal": "8669008522", "noe_summarized": "1", "manufacturer_contact_l_name": "FORSYTHE", "source_type": [ "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "94404", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "866", "date_added": "20220328", "manufacturer_contact_f_name": "SHAWN", "device_date_of_manufacturer": "20220211", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "25548", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "N", "date_received": "20220324", "brand_name": "ULAB SYSTEMS DENTAL ALIGNER", "generic_name": "FG0094, ULAB SYSTEMS ALIGNER KIT", "manufacturer_d_name": "ULAB SYSTEMS", "manufacturer_d_address_1": "1820 GATEWAY DRIVE", "manufacturer_d_address_2": "", "manufacturer_d_city": "SAN MATEO", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "94404", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "94404", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20240211", "model_number": "FG0094", "catalog_number": "NA", "lot_number": "VEH99", "other_id_number": "", "device_availability": "No", "device_report_product_code": "NXC", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Aligner, Sequential", "medical_specialty_description": "Dental", "regulation_number": "872.5470", "device_class": "2" } } ], "product_problems": [ "Biocompatibility", "Biocompatibility" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250801", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "8669", "patient": [ { "patient_sequence_number": "1", "date_received": "20220324", "sequence_number_treatment": [ "FG0094, ULAB SYSTEMS USMILE ALIGNER KIT" ], "sequence_number_outcome": [ "Other" ], "patient_age": "14 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Hypersensitivity/Allergic reaction", "Hypersensitivity/Allergic reaction" ] } ], "distributor_city": "", "date_report": "20220317", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SAN MATEO", "mdr_report_key": "13891900", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20220224", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "94404", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "ULAB SYSTEMS, INC", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "289195912", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "WHO: THE DOCTORS OFFICE CALLED WITH THE PATIENT HAVE AN ALLERGIC REACTION DURING TREATMENT. ` WHAT: THE PATIENT HAD AN ALLERGIC REACTION TO THE ATTACHMENT MATERIAL USED FOR TREATMENT. WHEN:(B)(6) 2022. WHERE: THIS WAS NOTICED BY THE DOCTORS OFFICE AS THE PATIENT HAD AN ALLERGIC REACTION DURING TREATMENT. WHY: THE CAUSE OF THE PATIENTS ALLERGIC REACTION IS DUE TO THE ATTACHMENT MATERIALS, ADHESIVE AND GLUE USED FOR TREATMENT PER THE ATTACHED DOCTORS EMAIL. CONCLUSION: THE PATIENT WENT TO SEE AN ALLERGIST AND THE ALLERGIST ASKED FOR THE MSDS SHEET FOR OUR MATERIAL. THE PATIENT WENT THROUGH AN ALLERGIC REACTION TEST AND THE ALLERGIST REPORT SHOWS THE PATIENT IS ALLERGIC TO THE ADHESIVE AND GLUE USED DURING TREATMENT. THE ALLERGY REPORT ALSO SHOWS THAT THE PATIENT SCORED A \"IRRITANT REACTION\" TO THE ZENDURA FLX MATERIAL AS SEEN IN THE ATTACHED ALLERGY REPORT. THE DOCTORS OFFICE REPLIED TO ULABS FOLLOW UP EMAIL AND STATES THE PATIENT IS FINE AND WAS ALLERGIC TO ALL ATTACHMENT MATERIALS." }, { "mdr_text_key": "289195913", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ON 02/24/2022, ULAB SYSTEMS CLIENT SERVICES WAS NOTIFIED OF A PATIENT WITH A POTENTIAL MILD ALLERGIC REACTION TO THE USMILE ALIGNER WHICH IS MANUFACTURED USING THE ZENDURA FLX MATERIAL. THIS FEEDBACK WAS DOCUMENTED IN THE DOT COMPLIANCE EQMS AS A PRODUCT COMPLAINT- (B)(4), PER (B)(4), COMPLAINT HANDLING. THE SOURCE OF THE POTENTIAL ALLERGIC REACTION AND THE SEVERITY FOR THE PATIENT ARE UNKNOWN. ULAB SYSTEMS CLIENT SERVICES SENT FORWARDED AN MSDS SHEET FOR THE ZENDURA FLX MATERIAL SO THE ALLERGIST COULD RESEARCH THE ZENDURA FLX MATERIAL AS A POSSIBLE CAUSE OF THE PATIENT'S REACTION. THE PATIENT WENT THROUGH AN ALLERGIC REACTION PATCH TEST AND THE ALLERGIST REPORTED THAT THE PATIENT IS ALLERGIC TO THE ADHESIVE (+ REACTION) AND GLUE (++REACTION) USED DURING THE ATTACHING OF THE ORTHODONITC BRACKETS DURING THE TREATMENT. THE ALLERGY REPORT ALSO SHOWS THAT THE PATIENT SCORED A IR (IRRITANT REACTION) TO THE ZENDURA FLX MATERIAL AS SEEN IN THE ATTACHED ALLERGY REPORT. DUE TO THIS POTENTIAL ALLERGIC REACTION, THE ORTHODONTIST STOPPED ALL TREATMENT PLANNING FOR THIS PATIENT, INCLUDING THE FITTING OF ALIGNERS/TEMPLATE/RETAINERS. ON 3/15/2022, ULAB CLIENT SERVICES FOLLOWED UP WITH THE DOCTOR'S OFFICE FOR THE PATIENT WITH THE ADDITIONAL QUESTIONS BELOW: WHAT IS THE PATIENTS' HEALTH OUTCOME? IS THE ALLERGIC REACTION RESOLVED? DID THE PATIENT NEED MEDICAL ATTENTION LIKE MEDICATIONS OR SOMETHING ELSE TO RESOLVE THE ALLERGIC ISSUE? THE DOCTOR'S OFFICE RESPONDED WITH ONLY \"YES, EVERYTHING IS FINE. PATIENT WAS JUST ALLERGIC TO ALL ATTACHMENT MATERIALS\"." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "1820 GATEWAY DRIVE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "94404", "manufacturer_contact_exchange": "866", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }