It was reported by the customer contact that on (b)(6) 2023, within three days of use the patient developed a "violent dermatitis" it was reported that oral steroids and antibiotics were required due to the incident as well as wound care due to wound dehiscence.A sample was requested to be returned for evaluation.It has been determined that the reported event caused or contributed to serious injury.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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