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

Lot Number UNKNOWN

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

Patient Problem Cancer (3262)

Event Type  Injury  

Event Description

Cancer [cancer].Initial information received on 04-mar-2022 regarding a solicited valid serious case received from a consumer/non-hcp (non health care professional), 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 adult male patient who experienced cancer with the use of medical device 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, the patient started using synvisc one injection (strength, batch number, expiration date, frequency, indication: unknown).On an unknown date and latency, the patient developed a serious cancer (neoplasm malignant).This event was assessed as medically significant and required intervention.The patient mentioned that, he was more worried about the cancer than his knee.Action taken: unknown.It was not reported if the patient received a corrective treatment for the event (cancer).At time of reporting, the outcome was not recovered / not resolved for the event cancer.Reporter causality: not reported.Company causality: not reportable.A product technical complaint (ptc) was initiated on 07-mar-2022 for synvisc.Batch number: s1302; comet compliant id number: (b)(4).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 number 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 28 mar 2022 there are 32 complaints on file for lot number s1302 and all related sub-lots.30 complaints are on file for lot number s1302: (1) tip breakage, (1) extrusion issue, (1) barrel breakage and (27) adverse events.2 complaints are on file for lot number s13021: (1) extrusion issue and (1) tip breakage.Final investigation complete date was 30-mar-2022.Sanofi will continue to monitor complaints as stated in (b)(4) "product event handling" to determine if a capa is required.Additional information was received on 30-mar-2022 from the quality department.Global ptc number and ptc results added.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: 13992385
• MDR Text Key: 293836674
• Report Number: 2246315-2022-00032
• 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: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• 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): Required Intervention; Other
• Patient Sex: Male