MAUDE Adverse Event Report: ULAB SYSTEMS ULAB SYSTEMS USMILE ALIGNER; Aligner, sequential

Model Number	FG0094
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	07/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Who: the doctors office called stating that the patient had a potential allergic reaction during treatment with the usmile aligner.What: the patient had a potential allergic reaction to the zendura material used to manufacture the usmile aligner.When: (b)(6) 2023.Where: this doctor's office notified client services via a phone call that their patient had an allergic reaction to the zendura material why: client services replied via email to the doctor's office and provided the msds sheet for the zendura a and flx materials which is used to manufacturer the usmile aligners.Client services also asked the doctor office if the patient had any known allergies and the doctor's office replied: pending response.Conclusion: the cause of the patient's allergic reaction is undetermined.It is not known if the aligner material (zendura flx) or other materials used during the treatment (adhesives/attachment bonding/latex) caused the patient's allergic reaction.Pending receipt of the product per rma-0568 and evaluation by the quality engineer.No movement as of (b)(6) 2023 (label generated on (b)(6) 2023).Ulab systems reported this allergic reaction as an emdr through our webtrader production account, on (b)(6) 2023.
Additional Manufacturer Narrative
Who: the doctors office called stating that the patient had a potential allergic reaction during treatment with the usmile aligner.What: the patient had a potential allergic reaction to the zendura material used to manufacture the usmile aligner.When: (b)(6) 2023.Where: this doctor's office notified client services via a phone call that their patient had an allergic reaction to the zendura material why: client services replied via email to the doctor's office and provided the msds sheet for the zendura a and flx materials which is used to manufacturer the usmile aligners.Client services also asked the doctor office if the patient had any known allergies and the doctor's office replied: pending response.Conclusion: the cause of the patient's allergic reaction is undetermined.It is not known if the aligner material (zendura flx) or other materials used during the treatment (adhesives/attachment bonding/latex) caused the patient's allergic reaction.Pending receipt of the product per rma-0568 and evaluation by the quality engineer.No movement as of (b)(6) 2023 (label generated on (b)(6) 2023).Ulab systems reported this allergic reaction as an emdr through our webtrader production account, on (b)(6) 2023.

• Brand Name: ULAB SYSTEMS USMILE ALIGNER
• Common Device Name: Aligner, sequential
• Manufacturer (Section D): ULAB SYSTEMS; 7005 appling farms parkway; memphis TN 38133
• Manufacturer (Section G): ULAB SYSETMS; 7005 appling farms parkway; memphis TN 38133
• Manufacturer Contact: shawn forsythe ; 7005 appling farms parkway; memphis, TN 38133 ; 8669008522
• MDR Report Key: 17557479
• Report Number: 3017155477-2023-00006
• Device Sequence Number: 3435058
• Product Code: NXC
• UDI-Device Identifier: 00860002380056
• UDI-Public: 00860002380056
• 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
• Type of Report: Initial
• Report Date (Section B): 08/07/2023

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
• Device Expiration Date: 06/02/2025
• Device Model Number: FG0094
• Device Catalogue Number: N/A
• Device Lot Number: GPY09
• 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: 07/18/2023
• Initial Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2023
• 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