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

Lot Number UNKNOWN

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

Patient Problem Peripheral Edema (4578)

Event Type  Injury  

Event Description

Right knee, which became swollen the last time [injection site joint swelling].Case narrative: initial information received from united states on 14-mar-2023 regarding an unsolicited valid serious case received from u.S.Food & drug administration under reference mw5115356 via patient.This case involves an unknown age and gender patient whose right knee, which became swollen the last time while being treated with hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.At the time of the event, the patient had ongoing arthritis in knees.On an unknown date, the patient received first synvisc (hylan g-f 20, sodium hyaluronate) injection via route intra-articular (with an unknown dose, frequency, expiry date and batch number, strength: 16 mg/2 ml) for knee arthritis.Information on batch number and expiry date was requested.The doctor knew patient had an adverse reaction to synvisc, which also contains hyaluronic acid.The patient's right knee, which became swollen the last time (injection site joint swelling, onset date and latency: unknown).The patient cancelled the second and third injections of synvisc.The patient had injections of euflexxa into the knees last friday(b)(6) 2023).Knees also became swollen the day after the injection.Patient was seeing his/her doctor this week and was planning to ask him to aspirate his/her knee, which was more than twice its size.It was unknown if there were lab data/results available.Action taken: drug withdrawn and hylan g-f 20, sodium hyaluronate (synvisc) was discontinued on an unknown date.It was not reported if the patient received a corrective treatment for the event.At time of reporting, the outcome was unknown for the event.Seriousness criteria: medically significant.A product technical complaint (ptc) was initiated on 14-mar-2023 for synvisc (unknown batch number) with global ptc number 100332132.Sample of ptc was not available complaint: adverse event.Preliminary assessment (b)(6) 2023) based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction, death, or serious injury.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.The defect class has been updated to ii.Investigation (b)(6) 2023).The product lot number was not provided.A batch record review is not possible.Based on the lack of information, no assessment is possible.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 nonconforming material or product process.Sanofi will continue to determine if a capa (corrective and preventive action) is required.The final investigation was completed on 05-jun-2023 with summarized conclusion as no assessment possible.Additional information was received on 01-jun-2023 (non-significant) from non-hcp and 05-jun-2023 (significant) from other health care professional (both were processed together).Global ptc number, strength and result was 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: 17097463
• MDR Text Key: 316939711
• Report Number: 2246315-2023-00064
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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