MAUDE Adverse Event Report: ULAB SYSTEMS ULAB SYSTEMS DENTAL ALIGNER; CLEAR ALIGNER, PRODUCT CODE: NXC

Model Number	FG0094
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	10/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
None.
Event or Problem Description
Who: the doctor contacted ulab regarding a possible allergic reaction.What: "i saw a patient today because his gums were irritated from the aligners.He said he didn't have any issues with aligner #1, but now he is having issues with aligner #2.It is mainly the upper 1st & 2nd molar area on the inside and outside gingival area.The lower gums at the lower 1st molars were slightly irritated as well.I polished the gingival area and papilla area, so hopefully that will help.However, the strange part is the aligners don't really touch the gums except for the papilla area.That is why i don't know if the polishing will do anything.I started to think he could be having an allergic reaction, but it should have happened with aligner #1.However, allergic reactions tend to get worse over time like he could have had slight irritation with aligner #1, but now it has gotten worse with aligner #2 enough to really notice it." when: (b)(6) 2024 where: chairside while delivering the aligners to the patient.Why: no rma no manufacturing defects.Inspected at qa03 by #241 on (b)(6) 2024.Per discussion in the complaint meeting on (b)(6) 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) or if materials used by the other company when placing the bonded wire caused the patient's allergic reaction.As we don't have any information, 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.The doctor provided the symptoms the patient displayed and that the patient had no known allergies.The product was not returned.Ulab systems reported this minor allergic reaction as an emdr through our webtrader production account, on (b)(6) 2024.

• Brand Name: ULAB SYSTEMS DENTAL ALIGNER
• Common Device Name: CLEAR ALIGNER, PRODUCT CODE: NXC
• Manufacturer (Section D): ULAB SYSTEMS; 7005 appling farms pkwy; memphis TN 38113
• Manufacturer (Section G): ULAB SYSTEMS; 7005 appling farms pkwy; memphis TN 38113
• Manufacturer Contact: aswin srinivasan ; 7005 appling farms pkwy; memphis, TN 38113 ; 8669008522
• MDR Report Key: 20735477
• Report Number: 3017155477-2024-00013
• Device Sequence Number: 8287397
• Product Code: NXC
• UDI-Device Identifier: 00860002380094
• UDI-Public: 00860002380094
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/20/2024

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 Expiration Date: 04/25/2026
• 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: 10/28/2024
• Initial Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2024
• 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: Male