Severe pain in his right arm accompanied by herpes zoster like rash [painful r arm].Severe pain in his right arm accompanied by herpes zoster like rash [rash over arms].Case narrative: initial information was received on 14-dec-2020 regarding an unsolicited valid serious case from a physician via health authorities of united states under reference mw5097902.This case involves an unknown age male patient who experienced severe pain in his right arm accompanied by herpes zoster like rash after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.On (b)(6) 1998, the patient received third injection of synvisc (hylan g-f 20, sodium hyaluronate) via intra-articular route (dose, frequency, indication and lot - unknown).There would be no information available on the batch number of this case.On (b)(6) 1998, 4 days after the third injection of hylan g-f 20 and sodium hyaluronate, the patient developed severe pain in his right arm (pain in extremity) accompanied by herpes zoster like rash (rash).This event was assessed as medically significant.The reporting physician had another patient who had a similar rash after 5 injections of hyalgan.Final diagnosis was severe pain in his right arm accompanied by herpes zoster like rash.Action taken: not applicable for both events.It was not reported if the patient received a corrective treatment for both events.The patient outcome is reported as unknown for severe pain in his right arm accompanied by herpes zoster like rash.A product technical complaint (ptc) was initiated on 14-dec-2020 for synvisc.Batch number: unknown; global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review is not possible.Based on lack of information provided, no capa (corrective and preventive action) was required.It was the requirement to review all finished batch records for specification conformation prior to release.Any out of specification result is identified and mitigated through the ncr (non-conformances report) process.Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers and assesses possible associations with their corresponding product lot, as part of routine surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi would continue to monitor if a capa is required.Investigation complete date: 23-dec-2020.Additional information was received on 14-dec-2020 from health care professional.Global ptc number was added.Text was amended accordingly.Additional information was received on 23-dec-2020 from other healthcare professional (genzyme event management group).Global ptc number and its results were added.Clinical course updated.Text amended accordingly.
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