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

Lot Number UNKNOWN

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

Patient Problems Pain (1994); Swelling (2091); Synovitis (2094)

Event Date 01/28/1999

Event Type  Injury  

Event Description

Acute synovitis [acute synovitis] ([swelling of l knee], [aching (l) knee]) case narrative: initial information received on (b)(6) 2021 regarding an unsolicited valid serious case received from health authorities of united states under reference mw5097755 via pharmacist.This case involves adult patient who experienced acute synovitis, 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 in 1999, the patient started using hylan g-f 20, sodium hyaluronate at unknown dose and frequency via intra-articular route (lot - unknown) for unknown indication in left knee.On (b)(6) 1999 after a latency of few days, patient experienced significant swelling (joint swelling) and pain in knee (arthralgia) which was assessed as acute synovitis (synovitis).Patient went on a trip between first and second injections but later received the second and third injection.Action taken: no action taken it was not reported if the patient received a corrective treatment.The patient outcome is reported as recovered / resolved product technical complaint (ptc) was initiated with global ptc number 100094386 on 08-jan-2021 for product.Batch number; unknown device not returned.The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa (corrective and preventive action) was required.It was the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result was identified and mitigated through the ncr (non-conformance report) process.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 had not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required final investigation complete date: (b)(6) 2021 follow up was received on (b)(6) 2021 from healthcare professional.Global ptc number added.Text amended accordingly.Additional information was received on (b)(6) 2021 from healthcare professional.Global ptc results added.Text was 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: 11256923
• MDR Text Key: 229593723
• Report Number: 2246315-2021-00050
• 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: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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): Other; Required Intervention