Burning up but had no fever [feeling hot].Excruciating pain [aching (r) knee].Synvisc treatments have only lasted for 4.5 months [therapeutic product effect decreased].Case narrative: initial information received on 14-dec-2020 regarding an unsolicited valid serious case received from non-healthcare professional via health authorities of united states under reference mw5097794.This case is cross-referenced with (b)(4) (first injection left knee for 5th series), (b)(4)(second injection left knee for 5th series), (b)(4) (third injection left knee for 5th series), (b)(4) (first injection right knee for 5th series), (b)(4) (second injection right knee for 5th series) and (b)(4) (4th series injection) (multiple devices).This case involves an unknown age female patient who was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc) and experienced excruciating pain which was worse in the left knee, burning up but had no fever and synvisc treatments have only lasted for 4.5 months.The patient's past medical history, vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing hypothyroidism since 1999 for 4 years, hypertension nos (not otherwise specified) since 2001 for 2 years and seasonal allergies (was not allergic to birds, feathers or eggs).Patient previously has 4 series of hylan g-f 20, sodium hyaluronate injections (from 2001 to 2002) for localized osteoarthritis.Concomitant medications included acetate tablet, levothyroxine sodium (synthroid); fexofenadine hydrochloride (allegra) and ramipril (altace).On an unknown date in 2003, the patient started 5th series of intra-articular injection of hylan g-f 20, sodium hyaluronate at the dose of 2 ml every week for 2 weeks in right knee (lot: unknown) for localized osteoarthritis.There will be no information available on the batch number for this case.On an unknown date in 2003 (by 11:00), after the third injection, patient had excruciating pain which was worse in the left knee (arthralgia) and was burning up but had no fever (feeling hot) (latency: unknown).Patient missed next 2 days of work and used a cane.It was also reported that the hylan g-f 20, sodium hyaluronate treatment only lasted for 4.5 months (therapeutic product effect decreased, onset: 2003, latency: unknown).Events of arthralgia and feeling hot were assessed as serious due to disability.Action taken: not applicable for all the events.Corrective treatment: not reported for all the events.Outcome: not applicable for therapeutic product effect decreased, unknown for rest of the events.A product technical complaint (ptc) was initiated on 14-dec-2020 for synvisc for unknown batch number and global ptc number: (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 (corrective and preventive action) 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 (non-conformances report) process.Adverse event reports with or without lot numbers were continuously monitored, and possible associations with their corresponding product lot are assessed, as part of routine safety surveillance effort to detect safety signals.This review has not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Investigation completion date: 04-jan-2021.Follow-up information received on 14-dec-2020 from other healthcare professional.Gptc number added.No significant information received.Additional information received on 04-jan-2021 from other healthcare professional.Investigation results added.Narrative amended accordingly.
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