(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 the mhra.Primevigilance did reach out to obtain more information 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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It was reported by the regulatory agency that the patient developed a rash, redness, spots, irritation, and itchiness when using chlorhexidine.Allergic to ametop.Has a rare neuro development genetic condition 14q duplication including foxg1 duplication.She's nearly (b)(6) and her ability is of a year old.Rash like sunburnt then blotchy then dark purple spots.Redness rash then spots, irritation, itchy seek advice details: was using piriton and e45 cream, it helped the redness but not the spots.
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