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

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

Patient Problem Missed Dose (2561)

Event Date 03/11/2020

Event Type  Injury  

Event Description

Missed dose (2 weeks late on his second dose) with no adverse event [missed dose].Case narrative: initial information received on 07-may-2020 regarding an unsolicited valid serious case received from health authorities of united states via patient (mw5094209).This case involves an unknown age male patient started treatment with hylan g-f 20, sodium hyaluronate (synvisc) and missed dose (2 weeks late on his second dose) with no adverse event.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date in 2020, the patient started treatment with hylan g-f 20, sodium hyaluronate injection (strength 8 mg/ml) and received his first 2 ml dose via intra articular route (batch number unknown) for unknown indication.Information on batch number was not requested in context of covid 19 crisis.On (b)(6) 2020, after unknown latency, patient missed dose and he was 2 weeks late on his second dose (medically significant).It was reported that he never received week 4 dose that was shipped to mdo on an unknown date in 2020, due to mdo being closed.Consultation dose on missed dose and it was advised to patient that label would be for maintenance dose due to second dose week four had been shipped to mdo.No more information provided.Action taken: not applicable.It was not reported if the patient received a corrective treatment.The patient outcome is reported as not applicable a product technical compliant (ptc) was initiated on (b)(6) 2020 for synvisc with unknown batch number and 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 has not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Investigation complete date: (b)(6) 2020.Additional information was received on 14-may-2020 from healthcare professional.Ptc results were added.Text amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• 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: 10122475
• MDR Text Key: 195723344
• Report Number: 2246315-2020-00064
• 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
• Report Date: 05/19/2020

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/05/2020
• 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): Other; Required Intervention