MAUDE Adverse Event Report: ULAB SYSTEMS ULAB SYSTEMS DENTAL ALIGNER; CLEAR ALIGNER

Model Number	FG0094
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	11/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Who: the doctor contacted ulab regarding the burning and fit/trim issue.Photos provided.Reva material.What: so the lower aligner looked fine when i took it out of the bag, but once it is inserted, it raises up/out at ll2.She came in with a large ball of wax (see photos).I trimmed the tray to see if that would help.She's coming back in today to let me know.I told her i would look into the "burning" aspect with you guys.But she's going on amazon and buying wax in bulk.When: on (b)(6) 2024.Where: no rma two pieces (u14b, u23b) rejected by #: (b)(6) on 9/4/2024 for cracks.Final qa03 inspection done by #: (b)(6) on 9/4/2024.Per review of the photos and discussion in the complaint meeting on 11/14/2024, possible allergic reaction.Cs to get more information regarding other allergies.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 11/20/2024.
Additional Manufacturer Narrative
None.

• Brand Name: ULAB SYSTEMS DENTAL ALIGNER
• Common Device Name: CLEAR ALIGNER
• Manufacturer (Section D): ULAB SYSTEMS; 7005 appling farms pkwy; memphis TN 38113
• Manufacturer Contact: aswin srinivasan ; 7005 appling farms pkwy; memphis, TN 38113 ; 8669008522
• MDR Report Key: 20737394
• Report Number: 3017155477-2024-00014
• Device Sequence Number: 8483865
• 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: 08/27/2026
• Device Model Number: FG0094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2024
• 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: Female