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 Arthralgia (2355); Joint Swelling (2356); Reaction, Injection Site (2442); No Code Available (3191)

Event Date 12/30/2014

Event Type  Injury  

Event Description

During injections felt some pressure [injection site pressure sensation], both knees become swollen with heat and severe pain, pain worse after injections [injection site joint swelling], both knees become swollen with heat and severe pain, pain worse after injections [injection site joint warmth], both knees become swollen with heat and severe pain, pain worse after injections [injection site joint pain].Case narrative: initial information received on 08-jan-2021 regarding an unsolicited valid serious case received from health authorities of united states under reference mw5097713 via patient.This case involves an adult patient (gender: unknown) who experienced during injections felt some pressure, both knees become swollen with heat and severe pain, pain worse after injections, 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.Concomitant medications included lisinopril; meloxicam (mobic); and multivitamin (vitamins nos).On (b)(6) 2014, the patient started using hylan g-f 20, sodium hyaluronate injection via intra-articular route (dose, frequency, indication, lot - unknown).Information on batch number was requested.On the same day, during injections, the patient felt some pressure (injection site discomfort) but no pain.On an unknown date in (b)(6) 2015, within 1 week after injection, patient's knees became swollen with heat and severe pain, pain worse after injections (injection site joint swelling, injection site joint warmth and injection site joint pain) and had continued for past 8 weeks.The patient spoke with doctor and he suggested therapy.The events were assessed as medically significant (serious injury).Action taken: unknown for all events.It was not reported if the patient received a corrective treatment.The patient outcome is reported as unknown for all events.A product technical complaint (ptc) was initiated on 08-jan-2021 for synvisc; batch number: unknown; global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa (corrective and preventive action) is required.It is the requirement to review all finished batch records for specification conformance prior to release.Any out of specification result is identified and mitigated through the ncr (non-conformance) 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 has not indicated any safety issue.Sanofi will continue to monitor complaints as stated in (b)(4) "product event handling" to determine if a capa is required.Final investigation was completed on 22-jan-2021.Additional information received on 08-jan-2021 from a physician.Clinical course was updated.Additional information was received on 22-jan-2021 from other healthcare professional.Gptc results were received and 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: 11236083
• MDR Text Key: 233143976
• Report Number: 2246315-2021-00042
• 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: 01/27/2021

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 Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/27/2021
• 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