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

Lot Number DRSL035

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

Patient Problem Injection Site Reaction (4562)

Event Type  Injury  

Event Description

Local reaction that required surgical wash out [injection site reaction].Case narrative: initial information was received from australia on 23-feb-2024 regarding an unsolicited serious case received from a pharmacist.This case is linked to case (b)(4) (multiple devices suspect for the same patient).This case involves an unknown-age male patient who experienced local reaction that required surgical wash out while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications, concomitant disease/condition, risk factors and family history were not provided.On (b)(6) 2024, the patient started taking hylan g-f 20, sodium hyaluronate injection of strength 16 mg/2ml (lot: drsl035, expiry date: june 2026) (unknown route, dose, frequency, indication).On an unknown date on (b)(6) 2024 and latency: few days, pharmacist had a patient who come in for a synvisc injection and apparently they bought the product from a pharmacy.After the injections in the last month and patient had a local reaction has occurred that required surgical wash out (injection site reaction; seriousness criteria: intervention required).At the point of injection the orthopaedic surgeon blocked the batch from being injected.He has apparently been in contact with the company, and have asked for some more formal correspondence to back up our "claim" - but wondering if there was possibility of returning this item or whether there was alternative batches available in the dc (distribution center).Patient have also requested a return approval given it is past our 7 day policy.Pharmacist never had an issue in the past so now doesn't want to inject any patients with the same batch number and has asked us to inject durolane instead.Pharmacist asked if the patient able to bring in the synvisc and exchange for the durolane otherwise patient will be (b)(4) out of pocket apparently.Action taken was unknown.Corrective treatment: surgical wash out.Outcome: unknown.Seriousness criteria: interventions required.

Manufacturer Narrative

Sanofi company comment dated 05-mar-2024: this case involves unknown age male patient who experienced local reaction that required surgical wash out while being treated with hylan g-f 20, sodium hyaluronate.Based on the limited information provided regarding this case, causal role of the company suspect product can not be excluded.However, more information of past and concomitant medication, any family history and any relevant medical history of patient, any concurrent conditions would aid in better case assessment.

Event Description

Local reaction that required surgical wash out [injection site reaction] case narrative: initial information was received from australia on 23-feb-2024 regarding an unsolicited serious case received from a pharmacist.This case is linked to case (b)(4) (multiple devices suspect for the same patient) this case involves an unknown-age male patient who experienced local reaction that required surgical wash out while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications, concomitant disease/condition, risk factors and family history were not provided.In january 2024, the patient started taking hylan g-f 20, sodium hyaluronate injection of strength 48 mg/ 6 ml (lot - drsl035, expiry date: 30-jun-2026) (unknown route, dose, frequency, indication) on an unknown date in jan-2024 and latency: few days, pharmacist had a patient who come in for a synvisc injection and apparently they bought the product from a pharmacy.After the injections in the last month and patient had a local reaction has occurred that required surgical wash out (injection site reaction; seriousness criteria: intervention required).At the point of injection the orthapaedic surgeon blocked the batch from being injected.He had apparently been in contact with the company, and had asked for some more formal correspondence to back up "claim" - but wondering if there was possibility of returning this item or whether there was alternative batches available in the dc (distribution center).Action taken was unknown.Corrective treatment: surgical wash out outcome: unknown.Seriousness criteria: interventions required.A product technical compliant was initiated on 23-feb-2024 for synvisc one with global ptc number: 100404197 (batch number: drsl035; expiry date: 30-jun-2026) sample status: available.Based on the complaint from intake team, there was no quality related defect that would attribute to a malfunction a death or serious injury.Sanofi global pharmacovigilance and epidemiology continuously monitors 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.The defect class had been updated to ii.(rc (b)(6) 2024) investigation: batch number drsl035, synvisc was manufactured on (b)(6) 2023 with expiration date of 30-jun-2026 yielding 2,180 singles.The incoming component inspection, packaging, and quality control documentation for this lot was reviewed.The investigation showed the product met specification at the time of release.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 nonconforming material or product process as per (b)(4).Furthermore, no associated non-conformances were noted for the issue defect at time of release.Trend analysis: there were two (2) complaints for mother lot drsl035 and sub-batches.Based on investigation and trend analysis, no capa required.Sanofi would continue to monitor adverse events.Trend analysis would be performed on a periodic basis as per (b)(4) "product event handling" to determine if a capa (corrective action and preventive action) was required.There was 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.This review had not indicated any safety issue.Final investigation completed on 11-mar-2024.Additional information was received on 11-mar-2024 from other healthcare professional.Suspect was updated to synvisc one from synvisc.Global ptc number added.Ptc results added.Text amended accordingly.

Event Description

Local reaction that required surgical wash out [injection site reaction].Case narrative: initial information was received from australia on 23-feb-2024 regarding an unsolicited serious case received from a pharmacist.This case is linked to case (b)(4) (multiple devices suspect for the same patient).This case involves an unknown-age male patient who experienced local reaction that required surgical wash out while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications, concomitant disease/condition, risk factors and family history were not provided.In (b)(6) 2024, the patient started taking hylan g-f 20, sodium hyaluronate injection of strength 48 mg/ 6 ml (lot - drsl035, expiry date: 30-jun-2026) (unknown route, dose, frequency, indication).On an unknown date in (b)(6) 2024 and latency: few days, pharmacist had a patient who come in for a synvisc injection and apparently they bought the product from a pharmacy.After the injections in the last month and patient had a local reaction has occurred that required surgical wash out (injection site reaction; seriousness criteria: intervention required).At the point of injection the orthapaedic surgeon blocked the batch from being injected.He had apparently been in contact with the company, and had asked for some more formal correspondence to back up "claim" - but wondering if there was possibility of returning this item or whether there was alternative batches available in the dc (distribution center).Action taken was unknown.Corrective treatment: surgical wash out.Outcome: unknown.Seriousness criteria: interventions required.A product technical compliant was initiated on (b)(6) 2024 for synvisc one with global ptc number: 100404197 (batch number: drsl035; expiry date: 30-jun-2026).Sample status: available.Based on the complaint from intake team, there was no quality related defect that would attribute to a malfunction a death or serious injury.Sanofi global pharmacovigilance and epidemiology continuously monitors 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.The defect class had been updated to ii.(rc 26feb24).Investigation: batch number drsl035, synvisc was manufactured on 17jul2023 with expiration date of 30-jun-2026 yielding 2,180 singles.The incoming component inspection, packaging, and quality control documentation for this lot was reviewed.The investigation showed the product met specification at the time of release.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 nonconforming material or product process as per rid-qu-sop-0040594.Furthermore, no associated non-conformances were noted for the issue defect at time of release.Trend analysis: there were two (2) complaints for mother lot drsl035 and sub-batches.Based on investigation and trend analysis, no capa required.Sanofi would continue to monitor adverse events.Trend analysis would be performed on a periodic basis as per rid-qu-sop-0000641 "product event handling" to determine if a capa (corrective action and preventive action) was required.There was 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.This review had not indicated any safety issue.The final investigation was completed on 11-mar-2024 and the summarized conclusion was no assessment possible.Additional information was received on 11-mar-2024 from other healthcare professional.Suspect was updated to synvisc one from synvisc.Global ptc number added.Ptc results added.Text amended accordingly.Based on the information previously received, qc comment and qc result have been added.Text amended accordingly.

• Brand Name: SYNVISC ONE
• 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: 18836762
• MDR Text Key: 336960644
• Report Number: 2246315-2024-00017
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: DRSL035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Sex: Male