MAUDE Adverse Event Report: ULAB SYSTEMS ULAB SYSTEMS USMILE DENTAL ALIGNER; FG0094, ULAB SYSTEMS USMILE ALIGNER

Model Number	FG0094
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	04/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Who: the doctors office called stating that the patient had an allergic reaction during treatment with the usmile aligner.What: the patient had an allergic reaction to the usmile aligner used for treatment and almost had to use an epi-pen.When: (b)(6) 2023 where: this doctor's office notified client services via email to report the patient's allergic reaction.Why: the doctor's office stated that the patient had an allergic reaction to the aligners that almost caused the patient to use an epi-pen.Client services replied via email to the doctor's office and provided the msds sheet for the zendura flx material which is used to manufacturer the usmile aligners and the msds sheet for the liquinox cleaner which is used to clean the usmile aligners.Client services also asked the doctor office if the patient had any known allergies and the doctor's office replied: autoimmune disease and possible relapsing polychondritis, chemical allergies to benzalkonium chloride, iodine, fragrance mix, propolis (beeswax) conclusion: the cause of the patient's allergic reaction is undetermined as the patient has several documented conditions and known allergies.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.Rma-0471 was returned and investigated by the quality engineer.The returned aligners do no show any observable conditions that might lead to an allergic reaction and the manufacturing lhr is complete and without issue.Ulab systems reported this allergic reaction as an emdr through our webtrader production account, on 04/28/2023.Refer to the attached medwatch fda esubmitter generated form 3500a- mfr report #: (b)(4).
Event or Problem Description
Doctors office called to state that their patient received her aligners and very shortly after placing the first set in mouth had an allergic reaction.The doctor's office washed and rinsed the aligners and gave them back to the patient and she then had a severe allergic reaction in which she almost had to use her epi-pen.The doctor's office has switched the patient to ceramic braces and discontinued treatment with the usmile clear aligners.The doctor's office requested to be credited for the case as the patient was only able to use 1 aligner set.A full credit request was approved and submitted to the doctor's office.Client services replied via email to the doctor's office and provided the msds sheet for the zendura flx material which is used to manufacturer the usmile aligners and the msds sheet for the liquinox cleaner which is used to clean the usmile aligners.Conclusion: the cause of the patient's allergic reaction is undetermined.The doctor's office responded to the client services email with the patient's known allergies/allergic reactions.The patient associated with this complaint had an allergic reaction to the either the aligner material, attachment materials, glues/adhesives, or rubber bands used in the treatment planning.Per the doctor, the patient has the following documented allergies: autoimmune disease and possible relapsing polychondritis, chemical allergies to benzalkonium chloride, iodine, fragrance mix, propolis (beeswax).It is undetermined if the aligner material (zendura flx) or other materials used during the usmile clear aligner treatment (adhesives/attachment bonding/latex) caused/contributed to the patient's allergic reaction.

• Brand Name: ULAB SYSTEMS USMILE DENTAL ALIGNER
• Common Device Name: FG0094, ULAB SYSTEMS USMILE ALIGNER
• Manufacturer (Section D): ULAB SYSTEMS; 7005 appling farms parkway; memphis TN 38133
• Manufacturer (Section G): ULAB SYSTEMS; 7005 appling farms parkway; memphis TN 38133
• Manufacturer Contact: shawn forsythe ; 7005 appling farms parkway; memphis, TN 38133 ; 8669008522
• MDR Report Key: 16802448
• Report Number: 3017155477-2023-00005
• Device Sequence Number: 7124814
• 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: 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
• Type of Report: Initial
• Report Date (Section B): 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Expiration Date: 02/22/2025
• Device Model Number: FG0094
• Device Catalogue Number: N/A
• Device Lot Number: GEC09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2023
• 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