MAUDE Adverse Event Report: ULAB SYSTEMS ULAB SYSTEMS USMILE 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	04/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Who: the doctor contacted ulab regarding a possible allergic reaction to aligners.What: the patient experienced a possible allergic reaction to aligners after few weeks of use.When: 4/12/2024 where: the aligners were in the patient's possession at the time of the allergic reaction.Why: the patient had a prior possible allergic reaction to previous aligners (jrn10).There has been no additional information regarding the patient's allergy history, etc, provided by the doctor.No rma issued.There was no manufacturing defects detected.The cause of the patient's reaction remains undetermined.It is not known if the aligner used during the treatment (adhesives/attachment bonding/latex) caused the patient's allergic reaction.As we don't have any information on the patient's allergy history, this reaction may be due to other external factors/common allergens that were introducted coincidentally at the time of the placement of the aligners, such as pollens, dust mites, pet allergens, biologic products, insect venoms.Conclusion: the cause of the possible allergic reaction is undetermined.Ulab systems reported this minor allergic reaction as an emdr through our web trader production account on 5/8/2024.Per sop0014, mandatory medical device reporting, section 8 (australia), this allergic reaction incident is not significant enough for the australia reportability criteria and will not be reported as an adverse incident to the ulab australian sponsor (emergo) or the relevant australian regulatory authority, per the reporting requirements/timelines and australian medical devices guidelines (argmd), chapter 22 post-market vigilance and monitoring requirements.
Additional Manufacturer Narrative
Who: the doctor contacted ulab regarding a possible allergic reaction to aligners.What: the patient experienced a possible allergic reaction to aligners after few weeks of use.When: 4/12/2024 where: the aligners were in the patient's possession at the time of the allergic reaction.Why: the patient had a prior possible allergic reaction to previous aligners (jrn10).There has been no additional information regarding the patient's allergy history, etc, provided by the doctor.No rma issued.There was no manufacturing defects detected.The cause of the patient's reaction remains undetermined.It is not known if the aligner used during the treatment (adhesives/attachment bonding/latex) caused the patient's allergic reaction.As we don't have any information on the patient's allergy history, this reaction may be due to other external factors/common allergens that were introducted coincidentally at the time of the placement of the aligners, such as pollens, dust mites, pet allergens, biologic products, insect venoms.Conclusion: the cause of the possible allergic reaction is undetermined.Ulab systems reported this minor allergic reaction as an emdr through our web trader production account on 5/8/2024.Per sop0014, mandatory medical device reporting, section 8 (australia), this allergic reaction incident is not significant enough for the australia reportability criteria and will not be reported as an adverse incident to the ulab australian sponsor (emergo) or the relevant australian regulatory authority, per the reporting requirements/timelines and australian medical devices guidelines (argmd), chapter 22 post-market vigilance and monitoring requirements.

• Brand Name: ULAB SYSTEMS USMILE ALIGNER
• Common Device Name: CLEAR ALIGNER
• Manufacturer (Section D): ULAB SYSTEMS; 7005 applying farms parkway; memphis TN 38133
• Manufacturer (Section G): ULAB SYSTEMS; 7005 applying farms parkway; memphis TN 38125
• Manufacturer Contact: gino rouss ; 7005 applying farms parkway; memphis, TN 38125
• MDR Report Key: 19274317
• Report Number: 3017155477-2024-00009
• Device Sequence Number: 7430559
• Product Code: NXC
• UDI-Device Identifier: 00860002380094
• UDI-Public: 00860002380094
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 05/08/2024

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: 03/26/2026
• 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: 04/14/2024
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2024
• 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 DENTAL ALIGNER KIT
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male