(b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).No additional information was provided by taylor gray, do, christopher white, do, maheera farsi, do, joseph dyer, do (authors of the journal entry).Propharma did reach out to obtain with no success.Should additional information be available in the future, the complaint will be re-opened and investigated.All complaints are reviewed during monthly quality/safety meetings.In addition, complaints are trended at monthly quality data analyst meetings and quarterly plant management review meetings.
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Material no.: unknown, batch no.: unknown.It was reported that the patient developed a rash on the knees and thickened palms and soles while using chlorhexidine.Per literature: a [omitted] adolescent with reported history of atopic dermatitis and recurrent superficial bacterial infections presented to our dermatology clinic for evaluation of a rash on the bilateral aspect of his knees, in addition to thickened palms and soles.
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