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

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

Patient Problems Emotional Changes (1831); Hot Flashes/Flushes (2153); Swelling/ Edema (4577)

Event Date 04/10/2001

Event Type  Injury  

Event Description

Wept for entire week (mood swings) [mood swings].Swelling of the legs [swelling of legs].Flushing of face and ankle [flushing].Case narrative: initial information received on 08-jan-2021 regarding an unsolicited valid serious case received from health authorities of united states under reference mw5097720 via patient.This case involves an adult patient who experienced swelling of the legs, flushing of face and ankle and wept for entire week (mood swings), while he/she was treated with 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 taking hylan g-f 20, sodium hyaluronate injection via intra-articular route (unknown dose, frequency, batch number, indication).On an unknown date after receiving the third injection of the series the patient developed swelling of the legs (peripheral swelling), flushing of face and ankle (flushing) and wept for entire week (mood swings) (mood swings).Patient was prescribed cortisone as corrective by the internist.Action taken: not applicable for all event.The patient was treated with cortisone for peripheral swelling, flushing and mood swings.The patient outcome is reported as recovering / resolving 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 sop rdg-sop-000440 "product event handling" to determine if a capa is required.Final investigation was completed on 29-jan-2021.Follow up was received on 08-jan-2021.Global ptc number was added.Additional information was received on 29-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: 11277696
• MDR Text Key: 230221505
• Report Number: 2246315-2021-00063
• 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
• 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): Required Intervention