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

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

Patient Problem Unspecified Infection (1930)

Event Date 05/01/2022

Event Type  Injury  

Event Description

Joint infection following injection of synvisc [joint infection] case narrative: initial information was received on 31-may-2022 regarding an unsolicited valid serious case from health authorities of united states under reference mw5109537.This case involves an unknown age and unknown gender patient who had joint infection following injection of hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical treatment(s), vaccination(s) and family history were not provided.The patient had no medical history, concomitant disease, or risk factor.On an unknown date, the patient started taking synvisc (hylan g-f 20, sodium hyaluronate) injection (liquid solution) (with strength: 16mg/2ml, an unknown batch number, expiry date, dose, frequency, route, indication).Information on batch number would not be available.On (b)(6) 2022, after unknown latency, the patient developed joint infection following injection of synvisc (arthritis infective).This event was assessed as medically significant.The patient was hospitalized for this event.It was unknown if the patient experienced any additional symptoms/events.There were no lab data/results available.Action taken: unknown.It was not reported if the patient received a corrective treatment for the event (joint infection following injection of synvisc).At time of reporting, the outcome was unknown for the event joint infection following injection of synvisc.A product technical complaint (ptc) was initiated on (b)(6) 2022 for synvisc (batch number: unknown) with global ptc number (b)(4).Sample status was not available.Ptc stated: complaint: adverse event; preliminary assessment: based on the complaint from intake team, there was no quality related defect that would attribute to a malfunction a death or serious injury.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.The defect class had been updated to ii.Investigation: the product lot number was not provided.A batch record review was not possible.Based on the lack of information, no assessment was possible.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 nonconforming material or product process.Sanofi would continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa (corrective and preventive action) was required.The final investigation was completed on (b)(6) 2023 and the summarized conclusion was "no assessment possible.".Additional information was received on 31-may-2022 from healthcare professional (quality department).Ptc number along with strength were added.Text amended accordingly.Additional information was received on 20-jun-2023 from healthcare professional (quality department).Ptc number 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: 17191037
• MDR Text Key: 317757062
• Report Number: 2246315-2023-00069
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/23/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/23/2023
• 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; Hospitalization; Other