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

Lot Number N1306

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment on 27-mar-2022: this case involves a (b)(6) female patient who was handicapped with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded.Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medications.

Event Description

Handicapped [handicap] case narrative: initial information received on 16-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".Patient id: (b)(6); country: (b)(6).Study title: patient support program involving synvisc.This case involves a (b)(6) female patient who was handicapped with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].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 hylan g-f 20, sodium hyaluronate injection (strength, expiration date, indication: unknown), at a dose of 3*2 ml (lot - n1306).Since an unknown date and latency, the patient was a little handicapped (disability).This event was assessed as medically significant and was leading to disability.Action taken: unknown.It was not reported if the patient received a corrective treatment for the event (handicapped).At time of reporting, the outcome was not recovered / not resolved for the event handicapped.Reporter causality: not reported.Company causality: not reportable.

Event Description

Handicapped [handicap].Case narrative: this case is linked to cases (b)(4) (multiple devices).Initial information received on 16-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".Patient id: (b)(6); country: canada.Study title: (b)(6).This case involves a 78 years old female patient who was handicapped with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].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 hylan g-f 20, sodium hyaluronate injection (16 mg/2 ml) (indication: unknown), at a dose of 2 ml thrice (lot - n1306; expiration date: 31-jan-2016).Since an unknown date and latency, the patient was a little handicapped (disability).This event was assessed as medically significant and was leading to disability.Action taken: unknown.It was not reported if the patient received a corrective treatment for the event (handicapped).At time of reporting, the outcome was not recovered / not resolved for the event handicapped.Reporter causality: not reported.Company causality: not reportable.Product technical complaint (ptc) was initiated with global ptc number 100209836 on 18-mar-2022 for synvisc.Batch number: n1306; expiration date: 31-jan-2016.The production and quality control documentation for lot number n1306 expiration date (2016-01) 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 n1306 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 30-mar-2022 there are (b)(4) complaints on file for lot number n1306 and all related sublots.(b)(4) complaints are on file for lot number n1306: (9) adverse event reports.(b)(4)complaint is on file for lot number n13061: (1) adverse event report.(b)(4) complaint is on file for lot number n13062: (1) adverse event report.Sanofi will continue to monitor complaints to determine if a capa is required.The final investigation was completed on 12-apr-2022 with summarized conclusion as no assessment possible.Additional information was received on 12-apr-2022 from other healthcare professional (from quality department).Gptc results were received and added.Text was amended accordingly.

• Brand Name: SYNVISC
• 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: 13930189
• MDR Text Key: 288047722
• Report Number: 2246315-2022-00025
• 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: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: N1306
• 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; Disability
• Patient Sex: Female