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

Lot Number UNKOWN

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 06/01/2020

Event Type  Injury  

Event Description

Allergic reaction [allergic reaction] ([swelling of l knee], [weight bearing difficulty], [shaking], [fever], [chills], [aching (l) knee], [joint range of motion decreased]).Case narrative: initial information received on 05-jan-2022 regarding a solicited valid non-serious case received from a patient, in the scope of post-marketing sponsored study "(b)(6)".Patient id: (b)(6); country: (b)(6).Study title: patient support program involving synvisc one.This case involves a (b)(6) female patient who had allergic reaction while being treated with 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 in (b)(6) 2020, the patient started taking hylan g-f 20, sodium hyaluronate injection liquid (solution) (strength: 48 mg/ 6 ml) at a dose of 6 ml once (with an unknown route, batch number, expiry date) for osteoarthritis.It was reported that patient had an allergic reaction (hypersensitivity; onset; (b)(6) 2020; latency: same day; seriousness: intervention required).Patient said that her knee became swollen, painful, there was difficulty bending or putting any weight on it (weight bearing difficulty, joint range of motion decreased; onset; (b)(6) 2020; latency: same day; seriousness: intervention required), she had fever (pyrexia; onset; (b)(6) 2020; latency: same day; seriousness: intervention required), the shakes (tremor; onset; (b)(6) 2020; latency: same day; seriousness: intervention required), and chills (onset; (b)(6) 2020; latency: same day; seriousness: intervention required).The following day she had a shot of cortisone by a sports medicine physician.Action taken with hylan g-f 20, sodium hyaluronate (synvisc one) was unknown.The patient was treated with cortisone for hypersensitivity at time of reporting, the outcome was recovered /resolved on an unknown date for the event allergic reaction.Seriousness criteria: intervention required for hypersensitivity.Product technical complaint (ptc) was initiated with global ptc number (b)(4) on (b)(6) 2022 for product synvisc.Batch number; unknown.Sample status: not available.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 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 will continue to monitor adverse events to determine if a capa is required final investigation complete date: 18-jan-2022 with summary code as no assessment possible.Reporter causality: not reported.Company causality: reportable.Additional information was received on 18-jan-2022 from healthcare professional.Global ptc result, form and strength added.Indication added.Age updated.Text was amended accordingly.

• Brand Name: SYNVISC ONE
• 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: 13363567
• MDR Text Key: 289274636
• Report Number: 2246315-2022-00008
• 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,Study,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/27/2022

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: UNKOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/27/2022
• 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): Required Intervention
• Patient Sex: Female