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

Lot Number UNKNOWN

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Fluid Discharge (2686)

Event Type  Injury  

Event Description

Draining [arthrocentesis].Having reaction [adverse reaction].Case narrative: initial information received on 16-sep-2021 regarding an unsolicited valid serious case received from a other health professional from (b)(6).This case involves a (b)(6) male patient who experienced draining and having reaction while being treated with hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate, injection, (formulation, batch number, route, indication, frequency: unknown).On the unknown date, after unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient had a reaction (adverse reaction) and had draining (aspiration joint) (intervention required) and cultures were sent.Action taken: unknown.It was not reported if the patient received a corrective treatment for the events (having reaction, draining).Outcome: unknown for both the events.

Event Description

Draining [arthrocentesis].Having reaction [adverse reaction].Case narrative: initial information received on (b)(6) 2021 regarding an unsolicited valid serious case received from a other health professional from united states.This case involves a 54-year-old male patient who experienced draining and having reaction while being treated with hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate, (formulation: solution for injection), (strength: 16 mg/ 2 ml) (batch number, route, indication, frequency: unknown).On the unknown date, after unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient had a reaction (adverse reaction) and had draining (aspiration joint) (intervention required) and cultures were sent.Action taken: unknown.It was not reported if the patient received a corrective treatment for the events (having reaction, draining).Outcome: unknown for both the events.A product technical complaint (ptc) was initiated on (b)(6) 2021 for synvisc with global ptc number: (b)(4) and results were pending for same.Additional information was received on 16-sep-2021 from the quality department.Global ptc number added.Strength and formulation added.Text amended accordingly.

Event Description

Draining [arthrocentesis].Having reaction [adverse reaction].Case narrative: initial information received on (b)(6) 2021 regarding an unsolicited valid serious case received from a other health professional from united states.This case involves a 54-year-old male patient who experienced draining and having reaction while being treated with hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate, (formulation: solution for injection), (strength: 16 mg/ 2 ml) (batch number, route, indication, frequency: unknown).On the unknown date, after unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient had a reaction (adverse reaction) and had draining (aspiration joint) (intervention required) and cultures were sent.Action taken: unknown.It was not reported if the patient received a corrective treatment for the events (having reaction, draining).Outcome: unknown for both the events.A product technical complaint (ptc) was initiated on (b)(6) 2021 for synvisc with global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa is required.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 ncr process.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.Sanofi will continue to monitor complaints to determine if a capa is required.Final investigation was completed was completed on (b)(6) 2021 and conclusion was summarized as no assessment possible.Additional information was received on (b)(6) 2021 from the quality department.Global ptc number added.Strength and formulation added.Text amended accordingly.Additional information was received on (b)(6) 2021 from the quality department.Ptc results received and processed.Text amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 12517924
• MDR Text Key: 280834430
• Report Number: 2246315-2021-00154
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2021

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: No Information
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2021
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/27/2021; 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention