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.
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