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

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

Patient Problem Stroke/CVA (1770)

Event Type  Injury  

Event Description

Stroke [stroke].Case narrative: this case is cross referenced with case: (b)(4) (cluster case).Initial information received on 12-mar-2019 from united states regarding an unsolicited valid serious case received from a non-healthcare professional this case involves a (b)(6) male patient who experienced stroke, 2 days after, he used the medical device of hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient took hylan g-f 20, sodium hyaluronate injection at unknown dosage unknown frequency via intra-articular route (lot number- unknown) for unknown indication.On the unknown date, patient experienced a stroke after 2 days of injection.Final diagnosis was stroke.Corrective treatment: not reported for stroke.Outcome: unknown for stroke.Seriousness criteria: medically significant for stroke.A product technical complaint was initiated, and results were pending for same.

Event Description

Stroke [stroke].Case narrative: this case is cross referenced with case: (b)(4).Initial information received on 12-mar-2019 from united states regarding an unsolicited valid serious case received from a non-healthcare professional this case involves a 43 years old male patient who experienced stroke, 2 days after, he used the medical device of hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient took hylan g-f 20, sodium hyaluronate injection at unknown dosage unknown frequency via intra-articular route (lot number- unknown) for unknown indication.On the unknown date, patient experienced a stroke after 2 days of injection.Final diagnosis was stroke.Corrective treatment: not reported for stroke.Outcome: unknown for stroke.Seriousness criteria: medically significant for stroke.A product technical complaint was initiated, for synvisc one (lot number unknown)on (b)(6) 2019 with global ptc number (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.It was 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 had not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Additional information was received on 18-mar-2019.Ptc results received and processed.Global ptc number added.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 8431954
• MDR Text Key: 139182702
• Report Number: 2246315-2019-00094
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 43 YR