(b)(4).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).No additional information was provided.Primevigilance 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 the patient developed an allergy to chloraprep, drug hypersensitivity, and itching.Per (b)(4).Developed an allergy to chloraprep (drug hypersenstivity) per (b)(4).Possible chloraprep or dressing allergy (application site allergy) itching (application site itching) application site pruritis.
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