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 Date 01/01/2024

Event Type  Injury  

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 has occurred that required surgical wash out [injection site reaction].Case narrative: initial information 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 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.In (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 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 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 $500 out of pocket apparently action taken was unknown.Corrective treatment: surgical wash out.At time of reporting, the outcome was unknown for the event.

Event Description

Local reaction has occurred that required surgical wash out [injection site reaction] case narrative: initial information received from australia on 23-feb-2024 regarding an unsolicited valid serious case received from a pharmacist.This case is linked to case (b)(4).(multiple devices suspect for 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/6ml (lot - drsl035, expiry date: 30-jun-2026) (unknown route, dose, frequency, indication).On an unknown date in jan-2024 and latency: unknown, 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).The pharmacist had another patient who come in for a synvisc injection and apparently they bought the product from a pharmacy.At the point of injection the orthapaedic surgeon blocked the batch from being injected.Pharmacist never had an issue in the past so now didn't want to inject any patients with the same batch number and asked to inject durolane instead.It was unknown if there were lab data/results available.Action taken: not applicable.Corrective treatment: surgical wash out.At time of reporting, the outcome was unknown for the event.A product technical complaint (ptc) was initiated on 23-feb-2024 for synvisc one (batch number: drsl035, expiry date: 30-jun-2026) with global ptc number 100404197.The sample status was requested and awaited.Sample status was not available.Ptc stated: preliminary assessment: based on the complaint from intake team, there is 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 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.(26feb24).Investigation: (08mar24) batch number drsl035, synvisc was manufactured on 17jul2023 with expiration date of 30jun2026 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 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.Furthermore, no associated non-conformances were noted for the issue defect at time of release.Trend analysis: there are two (2) complaints for mother lot drsl035 and sub-batches.100400928 drsl0035c other pharmacovigilance event100404197 drsl035 allergic reaction.Based on investigation and trend analysis, no capa (corrective and preventive action) required.Sanofi will continue to monitor adverse events.Trend analysis will be performed on a periodic basis to determine if a capa was required.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.This review has not indicated any safety issue.The final ptc was completed on 11-mar-2024 with summarized conclusion as no assessment possible.Additional information was received on 23-feb-2024 from healthcare professional (quality department).Suspect was updated from synvisc to synvisc one.Ptc number along with expiry date and strength were added.Text amended accordingly.Additional information was received on 11-mar-2024 from quality department via other healthcare professional.Global ptc results were added.Text amended accordingly.

Event Description

Local reaction has occurred that required surgical wash out [injection site reaction] case narrative: initial information received from australia on (b)(6) 2024 regarding an unsolicited serious case received from a pharmacist.This case is linked to case 2024sa066496 (multiple devices suspect for 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/6ml (lot - drsl035, expiry date: 30-jun-2026) (unknown route, dose, frequency, indication) on an unknown date in (b)(6) 2024 and latency: unknown, 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).The pharmacist had another patient who come in for a synvisc injection and apparently they bought the product from a pharmacy.At the point of injection the orthapaedic surgeon blocked the batch from being injected.Pharmacist never had an issue in the past so now didn't want to inject any patients with the same batch number and asked to inject durolane instead.It was unknown if there were lab data/results available.Action taken: not applicable.Corrective treatment: surgical wash out at time of reporting, the outcome was unknown for the event a product technical complaint (ptc) was initiated on (b)(6) 2024 for synvisc one (batch number: drsl035, expiry date: 30-jun-2026) with global ptc number 100404197.The sample status was requested and awaited.Ptc was set in process and results were pending for the same.Additional information was received on (b)(6) 2024 from healthcare professional (quality department).Suspect was updated from synvisc to synvisc one.Ptc number along with expiry date and strength were added.Text amended accordingly.

Manufacturer Narrative

Sanofi company comment for follow-up dated on 23-feb-2024: new follow-up information received does not change the previous case assessment.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 cannot 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.

• 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: 18848246
• MDR Text Key: 337026269
• Report Number: 2246315-2024-00018
• 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: 03/15/2024

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 Operator: Health Professional
• Device Lot Number: DRSL035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2024
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/12/2024; 03/15/2024
• 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