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
Event or Problem Description
Who: the doctor contacted ulab regarding a possible allergic reaction.What: patient wore the aligners, tracking, everything was fine.When it was time to wear tray #8 (upper and lower), the patient broke out in rashes all over her body.The doctor advised the patient to go back to trays #7 to pinpoint if trays #8 was the issue, the patient's rashes cleared up.They then thought it was a fluke deal, had the patients progress to trays #8 (upper and lower), she broke out in rashes again.The patient has skipped to aligner #9 and they are waiting to see if she has a reaction.· if she does have a reaction, i would like to offer to remake aligners 7-11 upper 7-13 lower · i asked if they had #8 to ship back to us for investigation but the doctor does not have it at this time.The aligners are with the patient.· (b)(6) sent me the msds sheets, and i will send those to dr.(b)(6) and his team.When: (b)(6) 2024.Where: aligners were in the patient's possession at the time of the possible allergic reaction.As of (b)(6) 2024, there has been no additional information regarding the patient's allergy history, etc, provided by the doctor.Why: no rma.No manufacturing defects.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.Ulab systems reported this minor allergic reaction as an emdr through our webtrader production account, on 05/22/2024.
Additional Manufacturer Narrative
Who: the doctor contacted ulab regarding a possible allergic reaction.What: patient wore the aligners, tracking, everything was fine.When it was time to wear tray #8 (upper and lower), the patient broke out in rashes all over her body.The doctor advised the patient to go back to trays #7 to pinpoint if trays #8 was the issue, the patient's rashes cleared up.They then thought it was a fluke deal, had the patients progress to trays #8 (upper and lower), she broke out in rashes again.The patient has skipped to aligner #9 and they are waiting to see if she has a reaction.· if she does have a reaction, i would like to offer to remake aligners 7-11 upper 7-13 lower.· i asked if they had #8 to ship back to us for investigation but the doctor does not have it at this time.The aligners are with the patient.· (b)(6) sent me the msds sheets, and i will send those to dr.(b)(6) and his team.When: (b)(6) 2024.Where: aligners were in the patient's possession at the time of the possible allergic reaction.As of (b)(6) 2024, there has been no additional information regarding the patient's allergy history, etc, provided by the doctor.Why: no rma no manufacturing defects.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.Ulab systems reported this minor allergic reaction as an emdr through our webtrader production account, on 05/22/2024.

• Brand Name: ULAB SYSTEMS DENTAL ALIGNER
• Common Device Name: CLEAR ALIGNER
• Manufacturer (Section D): ULAB SYSTEMS; 7005 appling farms parkway; memphis TN 38113
• Manufacturer (Section G): ULAB SYSTEMS; 7005 appling farms pkwy; memphis TN 38113
• Manufacturer Contact: gino rouss ; 7005 appling farms pkwy; memphis, TN 38113 ; 8669008522
• MDR Report Key: 19371993
• Report Number: 3017155477-2024-00011
• Device Sequence Number: 7528423
• Product Code: NXC
• UDI-Device Identifier: 00860002380094
• UDI-Public: 00860002380094
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 05/22/2024

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: 09/12/2025
• 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: 05/22/2024
• 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 ALIGNER KIT
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown