MAUDE Adverse Event Report: ULAB SYSTEMS ULAB SYSTEMS DENTAL ALIGNER; FG0094, ULAB SYSTEMS ALIGNER KIT

Model Number	FG0094
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	02/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Who: the doctor contacted ulab regarding the possible allergic reaction.What: office called and said their patient was given their aligners this month and is reporting swelling and irritation of the tongue and throat.When: (b)(6) 2025.Where: aligners were in the patient's possession at the time of the possible allergic reaction.The office asked if we could send the msds for the material.Why; no rma.One piece was rejected for a hole on (b)(6) 2024.Final qa03 inspection done by #195 on (b)(6) 2024.Per discussion in the complaint meeting on 3/4/2025, requested more information from the doctor, such as known allergies, did the patient seek medical attention, did the symptoms stop once they discontinued use of the aligners? no response from the doctor.Conclusion: as we did not receive further information, this reaction may be due to other external factors/common allergens that were introduced coincidentally at the 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 possible allergic reaction as an mdr through out webtrader production account on 3/13/2025.
Additional Manufacturer Narrative
Who: the doctor contacted ulab regarding the possible allergic reaction.What: office called and said their patient was given their aligners this month and is reporting swelling and irritation of the tongue and throat.When: (b)(6) 2025.Where: aligners were in the patient's possession at the time of the possible allergic reaction.The office asked if we could send the msds for the material.Why; no rma.One piece was rejected for a hole on (b)(6) 2024.Final qa03 inspection done by #195 on (b)(6) 2024.Per discussion in the complaint meeting on 3/4/2025, requested more information from the doctor, such as known allergies, did the patient seek medical attention, did the symptoms stop once they discontinued use of the aligners? no response from the doctor.Conclusion: as we did not receive further information, this reaction may be due to other external factors/common allergens that were introduced coincidentally at the 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 possible allergic reaction as an mdr through out webtrader production account on 3/13/2025.

• Brand Name: ULAB SYSTEMS DENTAL ALIGNER
• Common Device Name: FG0094, ULAB SYSTEMS ALIGNER KIT
• Manufacturer (Section D): ULAB SYSTEMS; 7005 appling farms pkwy; memphis TN 38133
• Manufacturer (Section G): ULAB SYSTEMS; 7005 appling farms pkwy; memphis TN 38133
• Manufacturer Contact: aswinraj srinivasan ; 7005 appling farms pkwy; memphis, TN 38133 ; 8669008522
• MDR Report Key: 21595521
• Report Number: 3017155477-2025-00015
• Device Sequence Number: 8349879
• Product Code: NXC
• UDI-Device Identifier: 00860002380094
• UDI-Public: 00860002380094
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K192596
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: FG0094
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/24/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FG0094, ULAB SYSTEMS USMILE ALIGNER KIT
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown