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

Model Number	FG0094
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	06/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Who: the doctor contacted ulab regarding a possible allergic reaction.What: patient experienced headache and nausea along with sinus issues.When: (b)(6) 2025.Where: aligners were in the patient's possession at the time of the possible allergic reaction.Why: no rma.No manufacturing defects.Inspected at qa03 on 5/16/2025 by #241.Per discussion in the complaint meeting on 6/24/2025, requesting more information from the doctor regarding known allergies, did they seek medical attention, did the symptoms stop once they discontinued wearing the aligners? 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 07/17/2025.
Event or Problem Description
Who: the doctor contacted ulab regarding a possible allergic reaction.What: patient experienced headache and nausea along with sinus issues.When: (b)(6) 2025.Where: aligners were in the patient's possession at the time of the possible allergic reaction.Why: no rma.No manufacturing defects.Inspected at qa03 on 5/16/2025 by #241.Per discussion in the complaint meeting on 6/24/2025, requesting more information from the doctor regarding known allergies, did they seek medical attention, did the symptoms stop once they discontinued wearing the aligners? per office: can't breathe and face and lips swollen.No known allergies.No allergy test planned.Try a different aligner company or put him in braces.Had restorative work.He wants to switch to invisalign from another provider.Wearing part time.Maybe stopped over the weekend.Try a different material.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 07/17/2025.

• Brand Name: ULAB SYSTEMS DENTAL ALIGNER
• Common Device Name: FG0094, ULAB SYSTEMS SLIGNER 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: aswin srinivasan ; 7005 appling farms pkwy.; memphis, TN 38133 ; 8669008522
• MDR Report Key: 22575236
• Report Number: 3017155477-2025-00017
• Device Sequence Number: 18506019
• Product Code: NXC
• UDI-Device Identifier: 00860002380094
• UDI-Public: 00860002380094
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 07/17/2025

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
• Device Lot Number: HLH16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2025
• 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: Female