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

Lot Number CRSP014A

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

Patient Problems Peripheral Edema (4578); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/18/2023

Event Type  Injury  

Event Description

Yesterday calf was 2x the size of other; gone downsome since last night [calf swelling] left knee is very swollen [injection site joint swelling] knee is a little more warm to the touch [injection site joint warmth] case narrative: initial information received on 07-mar-2023 regarding an unsolicited valid serious case received from a pharmacist via health authorities of united states under reference mw5115146.This case is linked to duplicate case (b)(4).This case involves an unknown age male patient whose calf was 2x the size of other yesterday; gone down some since last night, left knee was very swollen and knee was a little more warm to the touch after the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.On (b)(6) 2023, the patient received second injection of hylan g-f 20, sodium hyaluronate injection in his left knee via intra-articular route (strength:16 mg/2 ml) (lot: crsp014a and expiry date: 31-aug-2025) (unknown indication, dose, frequency).Patient had his 2nd of 3 synvisc.Patient stated his left knee was very swollen (joint swelling) (latency: same day).The swelling started about 3pm yesterday afternoon.He stated yesterday his calf was 2x the size of his other, that has gone down some since last night (peripheral swelling) (latency: same day).The knee was a little more warm to the touch (joint warmth) (latency: same day), no redness.He did not have a fever.He had been using ice.Patient could not get here for an appointment before 4:30pm.It was unknown if the patient experienced any additional symptoms/events.It was unknown if there were lab data/results available.Action taken: unknown for all events.Corrective treatment: patient had been using ice for all events.Outcome: recovering for peripheral swelling and unknown for other events.Seriousness criteria: medically significant for all events.A ptc (product technical complaint) was initiated on 08-mar-2023, for synvisc (lot: crsp014a and expiry date: 31-aug-2025) with global ptc number (b)(4).The sample was not available.The ptc stated that based on the complaint from intake team, there was no quality related defect that would attribute to a death or serious injury.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reported 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.(tj (b)(6) 2023).Batch # crsp014a, synvisc was manufactured on 20sep2022 with expiration date of 31aug2025 yielding (b)(4) kits.The incoming component inspection, packaging, and quality control documentation for this lot was reviewed.The investigation showed the product met specification at the time of release.It was 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.Furthermore, no associated non-conformances were noted for the issue defect at time of release.Customer sample was not available.Root cause could not be determined.Trend analysis: there were a total of 5 complaints for mother lot crsp0104 and sub-batches.100292748 crsp014a plunger missing100302463 crsp014a leakage at injection site/ adverse event / syringe issue nos100310438 crsp014a adverse event 100310443 crsp014a adverse event100310469 crsp014a.Adverse event there was no quality related defect that would attribute to a 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.This review has not indicated any safety issue.Based on investigation and trend analysis, no capa (corrective and preventive action) required.Sanofi will continue to adverse events.Trend analysis will be performed on a periodic basis "product event handling" to determine if a capa was required.The final investigation was completed on 20-apr-2023 with summarized conclusion as no assessment possible.Upon internal review, case (b)(4) was identified to be duplicate of (b)(4).Hence, all the information from the case (b)(4) (to be deleted) has been merged in case (b)(4).Case (b)(4) received with clock start date of 10-mar-2023 would be deleted.Ptc details, strength, batch number and expiry date 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: 17116081
• MDR Text Key: 317061980
• Report Number: 2246315-2023-00065
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: CRSP014A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Sex: Male