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

Lot Number 5RSA004

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

Patient Problem Cyst(s) (1800)

Event Date 09/25/2015

Event Type  Injury  

Event Description

Baker's cyst [baker's cyst] ([knee pain], [knee swelling]).Case narrative: initial information received on 08-jan-2021 regarding an unsolicited valid serious case received from health authorities of united states under reference number: mw5097716.This case involves adult female patient who experienced baker's cyst, after 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 the unknown date of 2015, the patient started using hylan g-f 20, sodium hyaluronate, (formulation, dosage, frequency, route, indication: unknown) (lot number - 5rsa004; expiry date: 28-feb-2018).On (b)(6) 2015, after the unknown latency of initiating the treatment with hylan g-f 20, sodium hyaluronate, patient experienced that knee became swollen (knee swelling) and back of the knee was very painful (arthralgia).According to patient it was baker's cyst (synovial cyst) (medically significant).Action taken: not applicable.It was not reported if the patient received a corrective treatment.Outcome: unknown for baker's cyst.Reporter causality: not related.A product technical complaint (ptc) was initiated on 08-jan-2021 for synvisc for batch number: 5rsa004 and global ptc number: (b)(4).Adverse event reports with or without lot numbers are continuously monitored, and possible associations with their corresponding product lot were assessed, as part of routine safety surveillance effort to detect safety signals.The production and quality control documentation for lot number 5rsa004 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 the concerned lot number no capa (corrective and preventive action) was required.This review has not indicated any safety issue.As of 29-jan-2021 there were 8 complaints on file for lot number 5rsa004 and all related sub-lots: (2) leaky syringes, (5) adverse event reports & (1) tip breakage.Sanofi would continue to monitor adverse events to determine if a capa was required.Investigation completion date: 01-feb-2021.Additional information was received on 08-jan-2021 from other healthcare professional.Gptc number was added.Additional information was received on 01-feb-2021 from healthcare professional.Investigational results were added.Text amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• 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: 11277901
• MDR Text Key: 230223727
• Report Number: 2246315-2021-00064
• 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: health professional
• Type of Report: Initial
• Report Date: 02/04/2021

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: No Information
• Device Expiration Date: 02/28/2018
• Device Lot Number: 5RSA004
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/04/2021
• 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; Required Intervention