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	05/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Who: the doctor contacted ulab regarding a possible allergic reaction.What: dr.(b)(6) wanted to know what is used to clean aligners after manufacturing them.Patient possibly having an allergic reaction to cleaner.When: (b)(6) 2024.Where: chairside while delivering the aligners to the patient.Why: no rma issued.No manufacturing defects.Emailed dr.(b)(6) the sds on liquinox.Waiting on further information after he receives email and speaks more with patient.Per discussion in the complaint meeting on 5/2/2024, 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) 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 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.Upon request for further information, the doctor responded that the parts were cleaned with anti-bacterial soap and mouthwash, and the patient had no further issues.Ulab systems reported this minor allergic reaction as an emdr through our webtrader production account, on 05/21/2024.
Event or Problem Description
What: dr.(b)(6) wanted to know what is used to clean aligners after manufacturing them.Patient possibly having an allergic reaction to cleaner.When: (b)(6) 2024.Where: chairside while delivering the aligners to the patient.Why: no rma issued no manufacturing defects emailed dr.(b)(6) the sds on liquinox.Waiting on further information after he receives email and speaks more with patient.Per discussion in the complaint meeting on 5/2/2024, 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) 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 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.Upon request for further information, the doctor responded that after cleaning the parts with anti-bacterial soap and mouthwash, the patient had no further issues.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
• Manufacturer (Section D): ULAB SYSTEMS; 7005 applying farms pkwy; memphis TN 38113
• Manufacturer (Section G): ULAB SYSTEMS; 7005 applying farms pkwy; memphis TN 38113
• Manufacturer Contact: gino rouss ; 7005 applying farms pkwy; memphis, TN 38113
• MDR Report Key: 19366879
• Report Number: 3017155477-2024-00010
• Device Sequence Number: 20418358
• Product Code: NXC
• UDI-Device Identifier: 00860002380094
• UDI-Public: 00860002380094
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/01/2024

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: 04/24/2026
• 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: 05/01/2024
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2024
• 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 DENTAL ALIGNER KIT
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown