MAUDE Adverse Event Report: SYNVISC; MOZ

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

Patient Problems Virus (2136); Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

Illnesses stated including covid-19 [covid-19].Illnesses [ill-defined disorder].Case narrative: initial information was received on 14-sep-2020 regarding a solicited valid serious case from a physician, in the scope of patient support program "(b)(6)".Center id: unknown; patient id: (b)(6); country: united states study title: (b)(6).This case involves a (b)(6) male patient who had illnesses (ill-defined disorder) stated including covid-19, while he was treated with hylan g-f 20, sodium hyaluronate [synvisc].Medical history, past medical treatment(s), vaccination(s) and family history were not provided.Concomitant medication was unknown.On an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate at a dose of 6 ml for every 6 months via intra-articular route (with an unknown formulation, strength, batch number and expiration date) for knee pain.On an unknown date, (latency unknown) after the initiation of suspect drug therapy, the patient experienced illnesses (ill-defined disorder) stated including covid-19.Covid-19 was assessed as medically significant as per ime (important medical event) list.No action was taken with the suspect drug therapy.It was not reported if the patient received any corrective treatment.Event outcome was reported as unknown.Reporter causality was unassessable for the events with respect to the suspect drug hylan g-f 20 and sodium hyaluronate.Company causality was not reportable for the events with respect to the suspect drug hylan g-f 20 and sodium hyaluronate.Information regarding batch number was requested.No further information was reported.

Event Description

Covid-19 [covid-19].Case narrative: upon internal review on (b)(6) 2021, this case initially considered as serious was downgraded to non-serious as the event covid-19 was no longer in the ime ((important medical event) list.Initial information was received on (b)(6) 2020 regarding a solicited valid serious case from a physician, in the scope of patient support program "psp_saus.Tjo.012".Center id: unknown; patient id: (b)(6); country: united states study title: sanofi patient connection.This case involves a 39-year-old male patient who had covid-19, while he was treated with hylan g-f 20, sodium hyaluronate (synvisc).Medical history, past medical treatment(s), vaccination(s) and family history were not provided.Concomitant medication was unknown.On an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate 48 mg/6 ml injection, liquid (solution) at a dose of 6 ml for every 6 months via intra-articular route (with an unknown batch number and expiration date) for knee pain.On an unknown date, (latency unknown) after the initiation of suspect drug therapy, the patient had illnesses including covid-19.No ation was taken with respect to suspect drug.It was unknown if the patient received any corrective treatment.Outcome of the event was unknown.Reporter causality was unassessable for the event with respect to the suspect drug.Company causality was not reportable for the event with respect to the suspect drug.There will be no information regarding the batch number of the case.No further information was reported.Additional information regarding a product technical complaint (ptc) was initiated on (b)(6) 2020 for hylan g-f 20, sodium hyaluronate (synvisc one).Batch number and expiration date not reported.Global ptc number: (b)(4) was received on (b)(6) 2020.Sample status: not available.Complaint status: in progress.Strength and formulation of the suspect drug was updated.The previously coded event ill-defined disorder was deleted.The case was downgraded to non-serious as the event covid-19 is no longer in the ime list.Corresponding fields and narrative were updated accordingly.Local comments: *downgrade*.

• Brand Name: SYNVISC
• Type of Device: MOZ
• MDR Report Key: 10572076
• MDR Text Key: 208211825
• Report Number: 2246315-2020-00138
• 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,study
• Type of Report: Initial,Followup
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention