Lot Number UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Autoimmune Disorder (1732); Angioedema (4536)
|
Event Type
Injury
|
Event Description
|
Suspected this is an autoimmune reaction [autoimmune disorder nos].Suspecting angioedema in head [angioedema].Migraines [migraine].Elevated erythrocyte sedimentation rate [erythrocyte sedimentation rate high].Elevated c-reactive protein [c-reactive protein result high].Case narrative: initial information received on 29-jun-2023 regarding an unsolicited valid serious case received from a pharmacist from united states.This case is cross referenced with case id: (b)(4) multiple device suspect used for the same patient).This case involves 74 years old female patient who was suspecting angioedema in head, suspected this is an autoimmune reaction, elevated erythrocyte sedimentation rate, elevated c-reactive protein and had migraines, with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications, concurrent condition/ risk factors and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate with 1st injection in unspecified knee via route intra-articular (strength 16 mg/2 ml) (lot/ batch number, expiry date, dose, frequency, indication: unknown).Information on batch number was requested.Pharmacist thought that the patient had 2-injections a week apart but was not sure the number of injections, but knew it was at least two.On an unknown date the patient started experiencing migraines (migraine) 2-weeks after getting the synvisc injections.On an unknown date after an unknown latency the patient experienced elevated erythrocyte sedimentation rate (red blood cell sedimentation rate increased) and c-reactive protein (c-reactive protein increased); labs found after going to the emergency for having migraines.The er (emergency room specialist) was suspecting angioedema in head (angioedema); that it was suspected this is an autoimmune reaction (autoimmune disorder) (onset date and latency: unknown).The pharmacist was wanted to know any data on elevation in these labs associated with the use of synvisc.Relevant laboratory test results included: c-reactive protein - on an unknown date: elevated c-reactive protein.Red blood cell sedimentation rate - on an unknown date: elevated erythrocyte sedimentation rate.Action taken: not applicable for all events.It was not reported if the patient received a corrective treatment for all events.At time of reporting, the outcome was unknown for autoimmune disorder and angioedema; not recovered for rest all events.A product technical complaint (ptc) was initiated on 29-jun-2023 for synvisc.Batch number: unknown global ptc number: (b)(4).The sample of the ptc was not available and ptc was set in process.Additional information was received on 29-jun-2023 by quality department: ptc number added.Strength added, text amended.
|
|
Event Description
|
Suspected this is an autoimmune reaction [autoimmune disorder nos].Suspecting angioedema in head [angioedema].Migraines [migraine].Elevated erythrocyte sedimentation rate [erythrocyte sedimentation rate high].Elevated c-reactive protein [c-reactive protein result high].Case narrative: initial information received on 29-jun-2023 regarding an unsolicited valid serious case received from a pharmacist from united states.This case is cross referenced with case id: 2023sa205804 (multiple device suspect used for the same patient).This case involves 74 years old female patient who was suspecting angioedema in head, suspected this is an autoimmune reaction, elevated erythrocyte sedimentation rate, elevated c-reactive protein and had migraines, with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications, concurrent condition/ risk factors and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate with 1st injection in unspecified knee via route intra-articular (strength 16 mg/2 ml) (lot/ batch number, expiry date, dose, frequency, indication: unknown).Information on batch number was requested.Pharmacist thought that the patient had 2-injections a week apart but was not sure the number of injections, but knew it was at least two.On an unknown date the patient started experiencing migraines (migraine) 2-weeks after getting the synvisc injections.On an unknown date after an unknown latency the patient experienced elevated erythrocyte sedimentation rate (red blood cell sedimentation rate increased) and c-reactive protein (c-reactive protein increased); labs found after going to the emergency for having migraines.The er (emergency room specialist) was suspecting angioedema in head (angioedema); that it was suspected this is an autoimmune reaction (autoimmune disorder) (onset date and latency: unknown).The pharmacist was wanted to know any data on elevation in these labs associated with the use of synvisc.Relevant laboratory test results included: c-reactive protein - on an unknown date: elevated c-reactive protein.Red blood cell sedimentation rate - on an unknown date: elevated erythrocyte.Sedimentation rate.Action taken: not applicable for all events.It was not reported if the patient received a corrective treatment for all events.At time of reporting, the outcome was unknown for autoimmune disorder and angioedema; not recovered for rest all events.A product technical complaint (ptc) was initiated on 29-jun-2023 for synvisc (hylan g-f 20, sodium hyaluronate) (batch number: unknown) with global ptc number: 100340017 the sample was not available and ptc stated: based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction, death, or serious injury.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 safety surveillance effort to detect safety signals.The defect class has been updated to ii.(tj30jun2023).Investigation (tj 11jul2023).The product lot number was not provided.A batch record review is not possible.Based on the lack of information, no assessment is possible.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the nonconforming material or product process.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa (corrective and preventive action) is required.The final investigation was completed on 18-jul-2023 with summarized conclusion as no assessment possible.Additional information was received on 29-jun-2023 by quality department: ptc number added.Strength added, text amended.Additional information was received on 18-jul-2023 from quality department: ptc details with summarized conclusion added.Text was amended accordingly.
|
|
Search Alerts/Recalls
|
|