(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 (b)(6) hospital.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 that a rash had formed on their patients after using the 26ml hi-lite orange chloraprep. verbatim: "good afternoon, i am a rep with bd.One of my accounts in (b)(6); (b)(6).Hospital, reached out to me today informing me about a problem they have had with chloraprep.D,w.Operating room manager, informed me that different surgeons reported to her that they noticed a rash had formed on their patients after using the 26ml hi-lite orange chloraprep.I am working with him to find out user technique.But i wanted to report this problem.Please let me know if there is anything else you need.".
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