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

Lot Number 4RSK001

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

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Diabetic [diabetic].Case narrative: initial information received on 18-mar-2022 regarding a solicited valid serious case received from a consumer/non-hcp, in the scope of post-marketing sponsored study "spon_i_synvisc one".Patient id: unknown; country: (b)(6).Study title: patient support program involving synvisc one.This case involves a (b)(6) female patient who was diabetic while being treated 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 (b)(6) 2015, the patient started using hylan g-f 20, sodium hyaluronate injection (strength: 48 mg/6 ml), at the dose of 6 ml for once only (lot - 4rsk001) for unknown indication.On an unknown date, after the latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient was diabetic (diabetes mellitus) and received insulin for it.Action taken: not applicable.Corrective treatment: insulin for diabetes mellitus.At time of reporting, the outcome was not recovered / not resolved for the event diabetic.Reporter causality: not reported.Company causality: not reportable.A product technical complaint (ptc) was initiated on (b)(6) 2022 for synvisc-one (lot/batch number: 4rsk001) with global ptc number: (b)(4).The sample status of the ptc was not available and the ptc was set in process.Additional information was received on 31-mar-2022 from the quality department.Ptc details, strength were added.Text amended accordingly.

Event Description

Diabetic [diabetic].Case narrative: initial information received on 18-mar-2022 regarding a solicited valid serious case received from a consumer/non-hcp, in the scope of post-marketing sponsored study "spon_i_synvisc one".Patient id: unknown; country: canada.Study title: patient support program involving synvisc one.This case involves a 77-year-old female patient who was diabetic while being treated 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 (b)(6) 2015, the patient started using hylan g-f 20, sodium hyaluronate injection (strength: 48 mg/6 ml), at the dose of 6 ml for once only (lot - 4rsk001, (b)(6) 2017) for unknown indication.On an unknown date, after the latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient was diabetic (diabetes mellitus) and received insulin for it.Action taken: not applicable.Corrective treatment: insulin for diabetes mellitus.At time of reporting, the outcome was not recovered / not resolved for the event diabetic.Reporter causality: not reported.Company causality: not reportable.A product technical complaint (ptc) was initiated on (b)(6) 2022 for synvisc-one (lot/batch number: 4rsk001; (b)(6) 2017) with global ptc number: (b)(4) the sample status of the ptc was not available and the ptc stated that the production and quality control documentation for lot # 4rsk001 expiration date (2017-10) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot # batch record review & lot # frequency analysis for lot #4rsk001 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 (b)(6) 2022 there are (b)(4) complaints on file for lot# 4rsk001 and all related sublots.(b)(4) complaints are on file for 4rsk001: (24) adverse event reports and (2) tip breakages.Sanofi will continue to monitor complaints as stated in sop rdg-sop-000440 product event handling to determine if a capa is required.The final investigation was completed on 31-mar-2022 with summarized conclusion as no assessment possible.Additional information was received on 31-mar-2022 from the quality department.Ptc details, strength were added.Text amended accordingly.Based on information previously received, the following information have been amended.Ptc results were added.

• 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: 13995725
• MDR Text Key: 288505626
• Report Number: 2246315-2022-00038
• 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,Followup
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 10/31/2017
• Device Lot Number: 4RSK001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: 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: Female