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

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

Patient Problem No Code Available (3191)

Event Date 10/30/2020

Event Type  Injury  

Event Description

Surgery: case narrative: initial information was received on 01-dec-2020 regarding an unsolicited valid serious case from a patient via health authorities of united states under reference number: (b)(4).This case involves an unknown age male patient who had surgery, while he was treated with medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided.Concomitant medications included hydrochlorothiazide, irbesartan (avalide); diclofenac, and irbesartan.On an unknown date, the patient started using synvisc (hylan g-f 20, sodium hyaluronate) (48 mg/ml) via intra-articular route (formulation, dose, frequency, indication and lot - unknown).Information on lot number was requested.On (b)(6) 2020, after unknown latency, the patient had surgery.The patient was hospitalized for this event.Final diagnosis was surgery.Action taken: unknown.It was not reported if the patient received a corrective treatment.The patient outcome is reported as not applicable for surgery.Product technical complaint (ptc) was initiated with global ptc number: (b)(4) on (b)(6) 2020 for product; batch number: unknown.Device not returned.The product lot number was not provided, therefore, a batch record review was not possible.Based on the lack of information provided, no capa (corrective and preventive action) was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr (non-conformance report) process.Sanofi global pharmacovigilance and epidemiology would continuously monitor 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 will continue to monitor adverse events to determine if a capa was required final investigation complete date: 07-dec-2020.Additional information was received on 07-dec-2020 from healthcare professional.Global ptc results added.Text was 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: 10976228
• MDR Text Key: 220656106
• Report Number: 2246315-2020-00165
• 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: 12/09/2020

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/09/2020
• 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): Hospitalization; Required Intervention