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

Lot Number DRSL009

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

Patient Problem Cancer (3262)

Event Type  Injury  

Event Description

Cancer [cancer] case narrative: initial information was received on 09-feb-2024 regarding a solicited valid serious case received from a patient, in the scope of post-marketing sponsored study "spon_i_synvisc one".Patient id: unknown; country: (b)(6) study title: patient support program involving synvisc one.This case is linked with (b)(4) (multiple devices used in same patient).This case involves an adult female patient who had cancer while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].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 (b)(6) 2023, the patient received hylan g-f 20, sodium hyaluronate injection in left knee at a dose of 6 ml once via route intra-articular (strength: 48mg/6ml, lot - drsl009, with an unknown expiry date) for osteoarthritis.Patient mentioned that she was a cancer patient (neoplasm malignant) (unknown onset date and latency).When asked to provide more information about cancer she would not confirm and advised that only the doctor would know, and he already knows.It was unknown if the patient experienced any additional symptoms/events.Action taken: not applicable.It was not reported if the patient received a corrective treatment for the event.At time of reporting, the outcome was not recovered for the event.Reporter causality: not reported company causality: not reportable.Seriousness criteria: medically significant.

Event Description

Cancer [cancer].Case narrative: initial information was received on 09-feb-2024 regarding a solicited valid serious case from a patient, in the scope of post-marketing sponsored study "spon_i_synvisc one".Patient id: unknown; country: canada.Study title: patient support program involving synvisc one.This case is linked with case (b)(4) (multiple devices used in same patient).This case involves an adult female patient who had cancer while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].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 (b)(6) 2023, the patient received hylan g-f 20, sodium hyaluronate injection in left knee at a dose of 6 ml once via route intra-articular (strength: 48mg/6ml, batch number - drsl009, expiry date: 31-jan-2026) for osteoarthritis.Patient mentioned that she was a cancer patient (neoplasm malignant) (unknown onset date and latency).When asked to provide more information about cancer she would not confirm and advised that only the doctor would know, and he already knew.It was unknown if the patient experienced any additional symptoms/events.Action taken: not applicable.It was not reported if the patient received a corrective treatment for the event.At time of reporting, the outcome was not recovered for the event.Reporter causality: not reported.Company causality: not reportable.Seriousness criteria: medically significant.A product technical compliant (ptc) was initiated on 09-feb-2024 for synvisc one (batch number - drsl009, expiry date: 31-jan-2026) with global ptc number (b)(4).The sample of the ptc (product technical complaint) 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 - (dp 12feb24).The production and quality control documentation for lot # drsl009 expiration date (2026-01) was manufactured on 27feb23 packaged 5000 singles were reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot # batch record review & lot # frequency analysis for lot # drsl009 no capa (corrective action and preventive action) is required.As of 14feb24 there are 6 complaints on file for lot# drsl009 and all related sublots.6 complaints are on file for lot#drsl009: (1) syringe broken before use and (5) adverse event reports.Sanofi will continue to monitor complaints and trending to determine if a capa is required.The final investigation was completed on 21-feb-2024 and the summarized conclusion was 'no assessment possible.' additional information was received on 21-feb-2024 from quality department (other healthcare professional).Expiry date was added.Ptc results were received and added in the case.

• Brand Name: SYNVISC ONE
• 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: 18720937
• MDR Text Key: 335580147
• Report Number: 2246315-2024-00010
• 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,Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

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: DRSL009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/26/2024
• 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; Other
• Patient Sex: Female