MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC; MOZ

Lot Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Autoimmune Disorder (1732); Angioedema (4536)

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 06-jul-2023: this case concerns a 74 year old female patient who received synvisc injection and has er (emergency room) is suspecting angioedema in head, suspected this is an autoimmune reaction elevated erythrocyte sedimentation rate, elevated c-reactive protein and migraines.Based upon the information available, the causal role of the product cannot be denied for the occurrence of event.However, there is no information regarding the technique of injection and whether aseptic conditions were maintained during the injection.Lack of further information regarding patient¿s current clinical presentation, medical history, concomitant medications and other risk factors precludes the complete medical case assessment.

Event Description

Suspected this is an autoimmune reaction [autoimmune disorder].Er is suspecting angioedema in head [angioedema].Elevated erythrocyte sedimentation rate [erythrocyte sedimentation rate high].Elevated c-reactive protein [c-reactive protein increased].Migraines [migraine].Case narrative: initial information received on 29-jun-2023 regarding an unsolicited valid serious case received from a pharmacist and family member from united states.This case is cross referenced with case id: (b)(4).(multiple device suspect used for the same patient, synvisc 1st injection).This case involves a 74 years old female patient and er (emergency room) is suspecting angioedema in head, suspected this is an autoimmune reaction elevated erythrocyte sedimentation rate, elevated c-reactive protein and 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 synvisc (hylan g-f 20, sodium hyaluronate) with 2nd injection in unspecified knee via route intra-articular (lot/ batch number, expiry date, dose, frequency, strength, indication: unknown).Information on batch number and expiry date 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 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.

Event Description

Suspected this is an autoimmune reaction [autoimmune disorder] er is suspecting angioedema in head [angioedema] elevated erythrocyte sedimentation rate [erythrocyte sedimentation rate high] elevated c-reactive protein [c-reactive protein increased] migraines [migraine] case narrative: initial information was received on (b)(6) 2023 regarding an unsolicited valid serious case from a pharmacist and family member from united states.This case is cross referenced with case id: (b)(4) (multiple device suspect used for the same patient, synvisc 1st injection) this case involves 74 years old female patient for whom er (emergency room specialist) was suspecting angioedema in head, suspected this is an autoimmune reaction elevated erythrocyte sedimentation rate, elevated c-reactive protein and migraines with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), concomitant medications, concurrent condition/ risk factors and family history were not provided.On an unknown date, the patient started using synvisc (hylan g-f 20, sodium hyaluronate) with 2nd injection in unspecified knee 1 df (dosage form) qw via route intra-articular with strength: 16mg/2ml, (lot/ batch number, expiry date and indication: unknown).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 2-weeks after getting the synvisc injections.On an unknown date after few days 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 was suspecting angioedema in head (angioedema); that it was suspected as 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: unknown 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.Seriousness criteria: medically significant for autoimmune disorder and angioedema a product technical complaint (ptc) was initiated on (b)(6) 2023 for synvisc (batch number: unknown) with global ptc number (b)(4).The sample status was not available.Ptc stated: complaint: adverse event preliminary assessment: 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.Investigation: 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 (b)(6) 2023 with summarized conclusion as no assessment possible.Additional information was received on (b)(6) 2023 from other healthcare professional (quality department).Ptc number along with strength were added.Text amended accordingly.Additional information was received on (b)(6) 2023 from other healthcare professional (quality department).Ptc results were added.Text amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer (Section G): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 17269187
• MDR Text Key: 318568719
• Report Number: 2246315-2023-00078
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 74 YR
• Patient Sex: Female