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 Arthritis (1723)

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment follow up dated 12-jun-2023: follow up information received does not change previous company assessment.This case involves unknown age and unknown gender patient who experienced pseudo-septic reaction, swelling and pain with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded.Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medications.

Event Description

Pseudo-septic reaction [pseudoseptic arthritis] ([joint pain], [joint swelling]).Case narrative: initial information received from united states on 12-jun-2023 regarding an unsolicited valid serious case received from a other health professional.This case involves an unknown age and unknown gender patient who experienced pseudo-septic reaction with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), concomitant disease, risk factor, and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate injection, liquid (solution) (strength: 16 mg/2 ml) (batch number, expiry date, dose, frequency, route, indication - unknown).Information on the batch number was requested sanofi sales representative called to report an ae (adverse event).As per the sanofi sales representative, they have limited data regarding the ae since the health care facility did not report it to them and they came to know the ae during a sales presentation by medical assistant.On an unknown onset and latency patient had a pseudo-septic reaction (arthritis) as presented by swelling (joint swelling), pain (arthralgia) and the patient was hospitalized.The sanofi sales representative told mis(unspecified term) that they do not have any time frame of the incident and hospitalization of the patient.It was unknown if the patient experienced any additional symptoms/events.No lab data reported.Action taken: unknown.Corrective treatment: not reported.At time of reporting, the outcome was not recovered.Seriousness criteria: hospitalization.A product technical complaint (ptc) was initiated on 12-jun-2023 for synvisc (batch number: unknown) with global ptc number: (b)(4).The sample of the ptc (product technical complaint) was not available.Ptc was set in process and results were pending for the same.Follow up information received on 13-jun-2023 received from other healthcare professional.No significant information received.Text amended.Additional information was received on 12-jun-2023 from quality department via other healthcare professional.Suspect formulation, strength and global ptc number were added.Text amended accordingly.

Event Description

Pseudo-septic reaction [pseudoseptic arthritis] ([joint pain], [joint swelling]) case narrative: initial information was received from united states on 12-jun-2023 regarding an unsolicited valid serious case from a health professional.This case involves an unknown age and unknown gender patient who experienced pseudo-septic reaction with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient's past medical history, medical treatment(s), concomitant disease, risk factor, and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate injection (strength:16mg/2ml) (batch number, expiry date, dose, frequency, route, indication - unknown).Information on the batch number was requested sanofi sales representative called to report an ae (adverse event).As per the sanofi sales representative, they have limited data regarding the ae since the health care facility did not report it to them and they came to know the ae during a sales presentation by medical assistant.On an unknown onset and latency patient had a pseudo-septic reaction (arthritis) as presented by swelling (joint swelling), pain (arthralgia) and the patient was hospitalized.The sanofi sales representative told mis(unspecified term) that they do not have any time frame of the incident and hospitalization of the patient.It was unknown if the patient experienced any additional symptoms/events.No lab data reported.Action taken: unknown.Corrective treatment: not reported.At time of reporting, the outcome was not recovered.Seriousness criteria: hospitalization.A product technical complaint (ptc) was initiated on 12-jun-2023 for synvisc (hylan g-f 20, sodium hyaluronate) (batch number: unknown) with global ptc number: (b)(4) the sample was not available and ptc stated: 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 (tj 27jun2023) 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 monitor adverse events and perform trend analysis on a periodic basis to determine if a capa (corrective and preventive action) is required the final investigation was completed on 27-jun-2023 with summarized conclusion as no assessment possible.Follow up information received on 13-jun-2023 received from other healthcare professional.No significant information received.Text amended.Additional information was received on 12-jun-2023 from quality department via other healthcare professional.Suspect formulation, strength and global ptc number were added.Text amended accordingly.Additional information was received on 27-jun-2023 from quality department: ptc details with summarized conclusion 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: 17170857
• MDR Text Key: 317641372
• Report Number: 2246315-2023-00067
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 06/30/2023

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
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/21/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/30/2023
• 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