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

Lot Number 8RSL029A

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

Patient Problem Insufficient Information (4580)

Event Type  Death  

Event Description

Patient had passed away [death nos].Information received on 20-sep-2021 regarding a solicited valid serious case received from patient wife, in the scope of post-marketing sponsored study (b)(6).This case involves an elderly male patient who had passed away after 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 (b)(6) 2019, the patient started taking hylan g-f 20, sodium hyaluronate injection, dose 6 ml (lot - 8rsl029a) for unknown indication.The information regarding lot number was requested.On an unknown date in (b)(6) 2021, after approximate latency of 2 years, the patient had passed away (death).This event was assessed as medically significant and was leading to death.It is unknown if an autopsy was done.Action taken: not applicable.It was not reported if the patient received a corrective treatment for the event (patient had passed away).At time of reporting, the outcome was fatal for the event patient had passed away.Reporter causality- not reported.Company causality- not reportable.

Event Description

Patient had passed away [death nos] case narrative: initial information received on 20-sep-2021 regarding a solicited non-valid serious case received from patient wife, in the scope of post-marketing sponsored study "spon_i_synvisc one".Patient id: (b)(6); country: canada.Study title: patient support program involving synvisc one.This case involves an elderly male patient who had passed away after 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 (b)(6) 2019, the patient started taking hylan g-f 20, sodium hyaluronate injection, liquid, (solution) (strength: 48 mg/6 ml) dose 6 ml (lot - 8rsl029a) for unknown indication.The information regarding lot number was requested.On an unknown date in (b)(6) 2021, after approximate latency of 2 years, the patient had passed away (death).The cause of death was unknown.This event was assessed as medically significant.It was unknown if an autopsy was done.Action taken: not applicable.It was not reported if the patient received a corrective treatment for the event (patient had passed away).At time of reporting, the outcome was fatal for the event patient had passed away.Reporter causality- not reported.Company causality- not reportable.A product technical complaint (ptc) was initiated with global ptc number (b)(4) on 21-sep-2021 for product.Batch number; 8rsl029a.Sample status: not available.The production and quality control documentation for lot number 8rsl029a; expiration date (2021-03) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot number batch record review & lot number frequency analysis for lot number 8rsl029a no capa was required.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed 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.As of 06-oct-2021 there were 13 complaints on file for lot number 8rsl029 and all related sublots.10 complaints was on file for lot number: 8rsl029a: (1) broken tip and (9) adverse event reports.1 complaint was on file for lot number: 8rsl029c: (1) leakage/llh, 2 complaints were on file for lot number 8rsl029: (2) adverse event reports.Final investigation complete date was 09-nov-2021.Sanofi would continue to monitor complaints as stated in sop rdg-sop-000440 "product event handling" to determine if a capa was required.Additional information was received on 09-nov-2021 from the other healthcare professional.Global ptc number and ptc results added.Text amended accordingly.Local comments: *downgrade*.

• 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: 12518104
• MDR Text Key: 272867099
• Report Number: 2246315-2021-00155
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 8RSL029A
• Was Device Available for Evaluation?: No
• 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; Death
• Patient Sex: Male