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

Model Number	FG0094
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682); Biocompatibility (2886); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	10/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, the doctors office informed ulab systems' client services group that their patient had a potential allergic reaction during their treatment to a usmile aligner.Why: no rma issued.Client services replied via email to the doctor's office and provided the msds sheet for the aligner material which is used to manufacturer the usmile aligners.Client services also asked the doctor if the patient had any known allergies, and the doctor responded that the patient is allergic to sulfa drugs (co-trimoxazole (septrin), sulfadiazine, sulfamethoxazole (gantanol), trimethoprim-sulfamethoxazole (bactrim, bactrim ds, septra, and septra ds), trimethoprim (trimpex, proloprim, and primsol), sulfasalazine (azulfidine en-tabs, azulfidine, and sulfazine), sulfisoxazole (gantrisin)) which are commonly used to treat bacterial infections.The doctor stated that the patient had a reaction with 2 aligners in the 1st refinement and 1 aligner in the 2nd refinement, which resulted in swelling for about 3-4 weeks.The doctor also stated "i'm not sure it was an allergy, because it was only 1 aligner.I had an invisalign patient that had a polyester allergy, that could not tolerate any aligners.This was lip swelling that imo, viral and it ran it's course".Conclusion: the cause of the patient's allergic reaction is undetermined.It is unknown if the reva material was the cause of the allergic reaction, if it was a viral infection that ran its course, or if other external factors / common allergens were introduced at same time as the aligner treatment, such as pollens, dust-mites, pet allergens, biologic products, insect venoms, or other orthodontic treatment materials including glues/adhesives, rubber bands, latex, or attachment materials used in the treatment planning.Per sop0014, mandatory medical device reporting ulab systems reported this allergic reaction as an emdr (form fda 3500a) through our webtrader production account, on 10/27/2023.Refer to the attached medwatch fda esubmitter generated form 3500a- mfr report #: 3017155477-2023-00007.
Additional Manufacturer Narrative
The cause of the patient's allergic reaction is undetermined.It is unknown if the aligner material was the cause of the allergic reaction, if it was a viral infection that ran its course, or if other external factors / common allergens were introduced at same time as the aligner treatment, such as pollens, dust-mites, pet allergens, biologic products, insect venoms, or other orthodontic treatment materials including glues/adhesives, rubber bands, latex, or attachment materials used in the treatment planning.Additionally, the doctor stated that the patient is allergic to sulfa drugs which are commonly used to treat bacterial infections.The doctor stated that the patient had a reaction with 2 aligners in the 1st refinement and 1 aligner in the 2nd refinement, which resulted in swelling for about 3-4 weeks.The doctor also stated "i'm not sure it was an allergy, because it was only 1 aligner.I had an invisalign patient that had a polyester allergy, that could not tolerate any aligners.This was lip swelling that imo, viral and it ran it's course".Per sop0014, mandatory medical device reporting ulab systems reported this allergic reaction as an emdr (form fda 3500a) through our webtrader production account, on 10/27/2023.Refer to the attached medwatch fda esubmitter generated form 3500a- mfr report #: 3017155477-2023-00007.

• Brand Name: ULAB SYSTEMS USMILE ALIGNER
• Common Device Name: CLEAR DENTAL ALIGNER
• 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: shawn forsythe ; 7005 appling farms pkwy; memphis, TN 38133 ; 8669008522
• MDR Report Key: 18023101
• Report Number: 3017155477-2023-00007
• Device Sequence Number: 7684455
• Product Code: NXC
• UDI-Device Identifier: 00860002380094
• UDI-Public: 00860002380094
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K192596N/A
• 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,Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 10/27/2023

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: 09/07/2025
• Device Model Number: FG0094
• Device Catalogue Number: N/A
• Device Lot Number: UJY10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2023
• 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 DENTAL ALIGNER KIT
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female