(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 mhrauk.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.
|
It was reported catheter site erythma.This case, biomarin case number (b)(4), is a spontaneous report from the (b)(6) referring to a [omitted] patient.This case was reported by a nurse.The patient's past medical history was not reported.The patient's concurrent conditions included: mucopolysaccharidosis iva.No allergies were reported.No concomitant medications were reported.On an unreported date, the patient initiated treatment with vimizim (55 milligram, qw, intravenous) for the indication of mucopolysaccharidosis iva.The lot number for vimizim was not reported.On (b)(6) 2021, the patient initiated treatment with chloraprep (dose, frequency, and route not reported) for the indication of infusion.The lot number for chloraprep was not reported.On (b)(6) 2021, the patient had 2 attempts at port access with the second attempt being successful.After 15 minutes of infusion, the patient experienced redness noted at the port site (catheter site erythema) due to chloraprep that was applied after the first failed attempt at port access.The site was uncovered, observed for an hour, and then the redness had self-resolved.No laboratory or diagnostic tests were reported.No treatment for the event was reported.Action taken with vimizim and chloraprep was not reported.
|