According to the customer, on (b)(6) 2023 the product caused "itchiness and skin irritation" after being applied for seven days.It was reported that due to this the patient required prescription triamcliolone ointment to treat the area.A sample was requested to be returned for evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
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