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 [cancer].Did not drive her car [impaired driving ability].Did not walk [walking difficulty].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 to (b)(4) (multiple devices suspect for same patient).This case involves elderly female patient who was diagnosed with cancer, did not walk and did not drive her car while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.On (b)(6) 2022, the patient started taking hylan g-f 20, sodium hyaluronate injection in left knee of strength: 16mg/2ml, at a dose of 6 ml once via intra-articular route (lot number: crsp002 and expiry date: unknown) for osteoarthritis.On an unknown date (latency: unknown), the patient was diagnosed with cancer (neoplasm malignant) therefore did not walk (gait disturbance) or drive her car (impaired driving ability).The patient finished her chemo in the beginning of (b)(6) 2023 and is now in remission.Action taken: not applicable for all the events.Corrective treatment: chemo (chemotherapy) for neoplasm malignant and not reported for all other events.Outcome: recovering for all the events.Reporter causality: not reported for all the events.Company causality: not reportable for all the events.Seriousness criteria: medically significant for neoplasm malignant; disability for impaired driving ability.

Event Description

Cancer [cancer] did not drive her car [impaired driving ability] did not walk [walking difficulty] 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 to case (b)(4) (multiple devices suspect for same patient) this case involves elderly female patient who was diagnosed with cancer, did not walk and did not drive her car while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.On the unknown date, the patient started taking hylan g-f 20, sodium hyaluronate injection in left knee of strength: 16mg/2ml, at a dose of 2 ml via intra-articular route (lot number and expiry date: unknown) for osteoarthritis.On an unknown date (latency: unknown), the patient was diagnosed with cancer (neoplasm malignant) therefore did not walk (gait disturbance) or drive her car (impaired driving ability).The patient finished her chemo in the beginning of april 2023 and is now in remission.Action taken: not applicable for all the events.Corrective treatment: chemo (chemotherapy) for neoplasm malignant and not reported for all other events outcome: recovering for all the events.Reporter causality: not reported for all the events company causality: not reportable for all the events a product technical compliant was initiated for synvisc (batch number; expiry date: unknown) with global ptc number: (b)(4).Seriousness criteria: medically significant for neoplasm malignant; disability for impaired driving ability.Additional information was received on 18-jan-2024 from the quality department.Global ptc number added.Start date, batch number and dosage updated.Text amended accordingly.

Event Description

Cancer [cancer].Did not drive her car [impaired driving ability].Did not walk [walking difficulty].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 to case (b)(4) (multiple devices suspect for same patient) this case involves elderly female patient who was diagnosed with cancer, did not walk and did not drive her car while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.On the unknown date, the patient started taking hylan g-f 20, sodium hyaluronate injection in left knee of strength: 16mg/2ml, at a dose of 2 ml via intra-articular route (lot number: crsp002 and expiry date: 31-dec-2024) for osteoarthritis.On an unknown date (latency: unknown), the patient was diagnosed with cancer (neoplasm malignant) therefore did not walk (gait disturbance) or drive her car (impaired driving ability).The patient finished her chemo in the beginning of april 2023 and is now in remission.Action taken: not applicable for all the events.Corrective treatment: chemo (chemotherapy) for neoplasm malignant and not reported for all other events.Outcome: recovering for all the events.Reporter causality: not reported for all the events company causality: not reportable for all the events a product technical compliant (ptc) was initiated on 18-jan-2024 for synvisc (batch number: crsp002; expiry date: 31-dec-2024) with global ptc number: 100394031.The 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.(rc 22jan24) investigation: (rc 29jan24) 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 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 fifteen (15) other complaints for mother lot crsp002 and sub-batches.100241024 crsp002 other adverse reaction nos100241038 crsp002 other adverse reaction nos100241039 crsp002 other adverse reaction nos100279307 crsp002 other pharmacovigilance event100279308 crsp002 other pharmacovigilance event100379309 crsp002 other pharmacovigilance event100279315 crsp002 other pharmacovigilance event100279313 crsp002 other pharmacovigilance event100279378 crsp002 other pharmacovigilance event100290128 crsp002 other pharmacovigilance event100290129 crsp002 other pharmacovigilance event100306100 crsp002 other pharmacovigilance event100394032 crsp002 other pharmacovigilance event100394031 crsp002 other pharmacovigilance event100395582 crsp002 other pharmacovigilance event 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 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.2024-01-29 dl: gmid changed to 425560 in accordance with information received by the site and expiration 31.12.2024 added.The final investigation was completed on 29-jan-2024 with summarized conclusion as no assessment possible.Seriousness criteria: medically significant for neoplasm malignant; disability for impaired driving ability.Additional information was received on 18-jan-2024 from the quality department.Global ptc number added.Start date, batch number and dosage updated.Text amended accordingly.Additional information was received on 29-jan-2024 from healthcare professional (quality department).Ptc results for lot number: crsp002 along with expiry date: 31-dec-2024 were added.Text amended accordingly.

• 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: 18561903
• MDR Text Key: 333441692
• Report Number: 2246315-2024-00002
• 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,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: 01/23/2024
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/29/2024; 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