Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bacterial Infection (1735)
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Event Type
Injury
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Event Description
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This unsolicited case from united states was received on 16-feb-2017 from a nurse.This case concerns a male patient of unknown age who started treatment with synvisc and after unknown latency experienced septic reaction and allergic reaction.No concomitant medications, concurrent condition, past drugs or medical history was reported.On an unknown date, the patient initiated treatment with synvisc injection (3 injection series) (dose, route, frequency and indication: not provided).It was reported that the patient experienced an adverse event with synvisc (the 3-injection series) about 10 years ago.It was reported that at some point during or after the synvisc injections the patient returned to the practice with a severely inflamed and filled up knee, and the knee was swollen so that it was huge (on an unknown date; latency: unknown).It was unknown whether it was the left knee of the right knee.It was reported that the patient had to have the knee drained a few times.The nurse was not sure whether it was a septic knee or an allergic reaction to synvisc, but the nurse thought it was more likely to have been an allergic reaction.Action taken: unknown.Corrective treatment: knee drained for allergic reaction and not reported for septic reaction.Outcome: unknown for both the events.A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Seriousness criteria: important medical event for septic reaction.No further details were available.Pharmacovigilance comment: (b)(4) comment dated 22-feb-2017: this case concerns a male patient who received treatment with synvisc injections and experienced knee inflammation, knee swelling and effusion and it is unknown if it was due to septic knee or allergic reaction.On the basis of reported information the causal role of suspect in occurrence of the events cannot be excluded.However, further information regarding final diagnosis, medical history, concurrent condition will aid in complete medical assessment of the case.
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Event Description
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This unsolicited case from united states was received on 16-feb-2017 from a nurse.This case concerns a male patient of unknown age who started treatment with synvisc and after unknown latency experienced septic reaction and allergic reaction.No concomitant medications, concurrent condition, past drugs or medical history was reported.On an unknown date, the patient initiated treatment with synvisc injection (3 injection series) (dose, route, frequency and indication: not provided).It was reported that the patient experienced an adverse event with synvisc (the 3-injection series) about 10 years ago.It was reported that at some point during or after the synvisc injections the patient returned to the practice with a severely inflamed and filled up knee, and the knee was swollen so that it was huge (on an unknown date; latency: unknown).It was unknown whether it was the left knee of the right knee.It was reported that the patient had to have the knee drained a few times.The nurse was not sure whether it was a septic knee or an allergic reaction to synvisc, but the nurse thought it was more likely to have been an allergic reaction.Action taken: unknown.Corrective treatment: knee drained for allergic reaction and not reported for septic reaction.Outcome: unknown for both the events.A pharmaceutical technical complaint (ptc) was initiated with (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Seriousness criteria: important medical event for septic reaction.No further details were available.Additional information was received on 22-feb-2017.Ptc results were added and text amended accordingly.Pharmacovigilance comment: sanofi company comment fo follow up dated 22-feb-2017: the follow up information received does not change previous case assessment.Sanofi company comment dated 22-feb-2017: this case concerns a male patient who received treatment with synvisc injections and experienced knee inflammation, knee swelling and effusion and it is unknown if it was due to septic knee or allergic reaction.On the basis of reported information the causal role of suspect in occurrence of the events cannot be excluded.However, further information regarding final diagnosis, medical history, concurrent condition will aid in complete medical assessment of the case.
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