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

Lot Number S1302

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

Patient Problem Neuropathy (1983)

Event Type  Injury  

Event Description

Has neuropathy in his hands.Case narrative: initial information received on 11-jan-2022 regarding a solicited valid serious case received from a consumer/non-healthcare professional, in the scope of post-marketing sponsored study "spon_i_synvisc one".Patient id: (b)(6); country: (b)(6).Study title: patient support program involving synvisc one.This case involves an elderly male patient who had neuropathy in his hands while being treated with hylan g-f 20, sodium hyaluronate, synvisc one.The patient's past medical treatment(s), vaccination(s) and family history were not provided.It was unknown if the patient had any medical history, concomitant disease, or risk factor.On (b)(6) 2014, the patient started taking hylan g-f 20, sodium hyaluronate injection at a dose of 6 ml once (lot - s1302; expiry date: apr-2016) (route and indication: unknown).On an unknown date the patient had neuropathy in his hands (neuropathy peripheral) (unknown latency) following the first dose intake of hylan g-f 20 and sodium hyaluronate.This event was assessed as medically significant.Physician did not consider that synvisc-one contributed to the patient's neuropathy.It was unknown if the patient experienced any additional symptoms/events.It was unknown if there were lab data/results available.Action taken: not applicable.It was not reported if the patient received a corrective treatment for the event (has neuropathy in his hands).At time of reporting, the outcome was not recovered for the event has neuropathy in his hands.Reporter causality: not related company causality: not reportable a product technical complaint (ptc) was initiated with global ptc number: (b)(4) on 12-jan-2022 for product.Batch number: s1302 sample status: not available the production and quality control documentation for lot number s1302 expiration date (2016-04) 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 #s1302 no capa is required.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.As of 07-feb-2022 there are 30 complaints on file for lot number s1302 and all related sub-lots.28 complaints are on file for lot number s1302: (1) tip breakage, (1) extrusion issue, (1) barrel breakage and (25) adverse events.2 complaints are on file for lot# s13021: (1) extrusion issue and (1) tip breakage.Final investigation complete date was 08-feb-2022.Sanofi will continue to monitor complaints as stated in sop rdg-sop-000440 "product event handling" to determine if a capa (corrective and preventive action) is required.Additional information was received on 08-feb-2022 from the quality department.Global ptc number and ptc results added.Text amended accordingly.Additional information was received on 22-jun-2022 from a physician.Case became medically confirmed.Reporter causality was updated from reported to not related.Text 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: 14836554
• MDR Text Key: 295048010
• Report Number: 2246315-2022-00071
• 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: Physician
• Type of Report: Initial
• Report Date: 06/27/2022

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 Operator: Health Professional
• Device Expiration Date: 04/01/2016
• Device Lot Number: S1302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/27/2022
• 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; Other
• Patient Sex: Male