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

Lot Number CRSP002

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

Patient Problems Cancer (3262); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Cancer.She had cancer therefore did not walk or drive her car [impaired driving ability].She had cancer therefore did not walk or drive her car [difficulty in walking].Case narrative: initial information received on 18-jan-2024 regarding a solicited valid serious case received from a patient, in the scope of post-marketing sponsored study "spon_i_synvisc".Patient id: unknown; country: canada study title: patient support program involving synvisc.This case is linked with case (b)(4) (multiple devices used in same patient).This case involves elderly female patient who had cancer, therefore did not walk or drive her car while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.It was unknown if the patient had any medical history, concomitant disease or risk factor.On an unknown date, the patient started taking synvisc (hylan g-f 20, sodium hyaluronate) injection in right knee (strength: 16mg/2ml, with an unknown dose, frequency, route, expiry date and batch number) for osteoarthritis.Information on batch number and expiry date was requested.The patient has had synvisc in both knees over the years for osteoarthritis.Patient reported that she finished her chemo in the beginning (b)(6) 2023 and was now in remission.She had cancer (neoplasm malignant) (unknown onset and latency) and therefore did not walk (gait disturbance, unknown onset and latency) or drive her car (impaired driving ability, unknown onset and latency).The patient also mentioned that during this time she did not receive any synvisc injections.It was unknown if there were lab data/results available.Action taken was unknown for all events.Corrective treatment: chemotherapy was received for the event cancer, not reported for other events.At time of reporting, the outcome was recovering / resolving for all events.Reporter causality: not reported for all events company causality: not reportable for all events seriousness criteria: disability for impaired driving ability and medically significant for neoplasm malignant.

Event Description

Cancer [cancer].She had cancer therefore did not walk or drive her car [impaired driving ability].She had cancer therefore did not walk or drive her car [difficulty in walking].Case narrative: initial information received on 18-jan-2024 regarding a solicited valid serious case received from a patient, in the scope of post-marketing sponsored study "spon_i_synvisc".Patient id: unknown; country: canada.Study title: patient support program involving synvisc.This case is linked with case (b)(6) (multiple devices used in same patient).` this case involves elderly female patient who had cancer, therefore did not walk or drive her car while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.It was unknown if the patient had any medical history, concomitant disease or risk factor.On an unknown date, the patient started taking synvisc (hylan g-f 20, sodium hyaluronate) injection, liquid (solution) in right knee (strength: 16mg/2ml, with an unknown dose, frequency, route) batch number: crsp002, expiration date 31-dec-2024 for osteoarthritis.Information on batch number and expiry date was requested.The patient has had synvisc in both knees over the years for osteoarthritis.Patient reported that she finished her chemo in the beginning apr-2023 and was now in remission.She had cancer (neoplasm malignant) (unknown onset and latency) and therefore did not walk (gait disturbance, unknown onset and latency) or drive her car (impaired driving ability, unknown onset and latency).The patient also mentioned that during this time she did not receive any synvisc injections.It was unknown if there were lab data/results available.Action taken was unknown for all events.Corrective treatment: chemotherapy was received for the event cancer, not reported for other events.At time of reporting, the outcome was recovering / resolving for all events.Reporter causality: not reported for all events.Company causality: not reportable for all events.Seriousness criteria: disability for impaired driving ability and medically significant for neoplasm malignant.A product technical complaint (ptc) was initiated on 18-jan-2024 for synvisc (lot/batch number: crsp002) with global ptc number: 100394032.The sample of the ptc was not available.Preliminary assessment: 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 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.Batch number crsp002, synvisc was manufactured on 07jan2022 with expiration date of 31dec2024 yielding 2,500 kits.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.Based on investigation and trend analysis, no capa required.Sanofi will continue to monitor adverse events.Trend analysis will be performed on a periodic basis as per rid-qu-sop-0000641 product event handling to determine if a capa is 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 investigation was completed on 30-jan-2024 with summarized conclusion as no assessment possible.Additional information was received on 18-jan-2024 from quality department: ptc number was added.Text was amended.Additional information was received on 30-jan-2024 from quality department: ptc details were added.Batch number and expiration date was added.Text was amended.

• Brand Name: SYNVISC
• Type of Device: MOZ
• 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: 18572765
• MDR Text Key: 333661816
• Report Number: 2246315-2024-00003
• 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: Foreign,Study,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

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 Lot Number: CRSP002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/01/2024
• 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): Disability; Other
• Patient Sex: Female