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

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated (b)(6) 2023.This case involves an unknown age female patient who had allergic reaction with synvisc-one (left knee) and needed to be aspirated a few times as a result of the swelling while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].The causal role of suspect device cannot be excluded for the event.Also, underlying condition of osteoarthritis could be a confounding factor for same.Also, patient was prone to allergies which could also be considered as a factor for the occurrence of reported events.However, further information regarding event onset, concomitant medications, knee status at baseline, injection technique and post injection routine would aid in further assessment of the case.

Event Description

Allergic reaction with synvisc-one [allergic reaction] ([aspiration joint], [injection site joint swelling], [injection site joint effusion].Case narrative: initial information received on (b)(6) 2023 regarding an unsolicited valid serious case received from united states via physician assistant.This case is linked to (b)(4), (multiple devices suspect for same patient).This case involves an unknown age female patient who had allergic reaction while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.She indicated that the patient is prone to allergies.On an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate injection (left knee) (with an unknown batch number, expiry date, dose, frequency, route, strength) for osteoarthritis.Information on the batch number was requested.She reported (unknown onset and latency) that she had a patient that had an allergic reaction with synvisc-one (hypersensitivity) when it was injected in both knees.The knees swelled up and needed to be aspirated a few times as a result of the swelling(injection site joint swelling) (aspiration joint) (injection site joint effusion) (unknown onset and latency).Action taken: was not applicable.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: event assessed as medically significant.A product technical complaint (ptc) was initiated, and the results were pending for the same.

Event Description

Allergic reaction with synvisc-one [allergic reaction] ([aspiration joint], [injection site joint swelling], [injection site joint effusion]).Case narrative: initial information received on 21-apr-2023 regarding an unsolicited valid serious case received from united states via physician assistant.This case is linked to case (b)(4) (multiple devices suspect for same patient).This case involves an unknown age female patient who had allergic reaction while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.She indicated that the patient is prone to allergies.On an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate injection (left knee) (with an unknown batch number, expiry date, dose, frequency, route) (strength: 48 mg/6 ml) for osteoarthritis.Information on the batch number was requested.She reported (unknown onset and latency) that she had a patient that had an allergic reaction with synvisc-one (hypersensitivity) when it was injected in both knees.The knees swelled up and needed to be aspirated a few times as a result of the swelling(injection site joint swelling) (aspiration joint) (injection site joint effusion) (unknown onset and latency).Action taken: was not applicable.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: event assessed as medically significant.A ptc (product technical complaint) was initiated on 21-apr-2023, for synvisc one (batch number and expiry date: unknown) with global ptc number (b)(4).The sample was not available.The ptc stated that it is in process.Additional information was received on 21-apr-2023 via quality department from other healthcare professional.Ptc details added; strength added.Text amended.

Event Description

Allergic reaction with synvisc-one [allergic reaction] ([injection site joint swelling], [injection site joint effusion]) aspirated a few times as a result of the swelling [aspiration joint].Case narrative: initial information received on 21-apr-2023 regarding an unsolicited valid serious case received from united states via physician assistant.This case is linked to case (b)(4), (multiple devices suspect for same patient).This case involves an unknown age female patient who had allergic reaction and aspirated a few times as a result of the swelling while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.She indicated that the patient is prone to allergies.On an unknown date, the patient received hylan g-f 20, sodium hyaluronate injection (left knee) (with an unknown batch number, expiry date, dose, frequency, route) (strength: 48 mg/6 ml) for osteoarthritis.Information on the batch number was requested.She reported (unknown onset and latency) that she had a patient that had an allergic reaction with synvisc-one (hypersensitivity) when it was injected in both knees.The knees swelled up and needed to be aspirated a few times as a result of the swelling(injection site joint swelling) (aspiration joint) (injection site joint effusion) (unknown onset and latency).Action taken: was not applicable.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: event assessed as medically significant.A ptc (product technical complaint) was initiated on 21-apr-2023, for synvisc one (batch number and expiry date: unknown) with global ptc number (b)(4).The sample was not received and the ptc stated: based on the complaint from intake team, there was no quality related defect that would pose as a malfunction.This complaint does not have a quality 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.Defect class has been updated to ii.The product lot number was not provided.A batch record review is 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 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) was required.(b)(6)).The final investigation was completed on 16-may-2023 with summarized conclusion as no assessment possible.Additional information was received on 21-apr-2023 via quality department from other healthcare professional.Ptc details added; strength added.Text amended.Additional information was received on 16-may-2023.Ptc details was added.Text amended accordingly.

Event Description

Allergic reaction with synvisc-one [allergic reaction] ([injection site joint swelling], [injection site joint effusion]) aspirated a few times as a result of the swelling [aspiration joint] case narrative: initial information received on 21-apr-2023 regarding an unsolicited valid serious case received from united states via physician assistant.This case is linked to case (b)(4) (multiple devices suspect for same patient) this case involves an unknown age female patient who had allergic reaction and aspirated a few times as a result of the swelling while being treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.She indicated that the patient is prone to allergies on an unknown date, the patient received hylan g-f 20, sodium hyaluronate injection (left knee) (with an unknown batch number, expiry date, dose, frequency, route) (strength: 48 mg/6 ml) for osteoarthritis.Information on the batch number was requested she reported (unknown onset and latency) that she had a patient that had an allergic reaction with synvisc-one (hypersensitivity) when it was injected in both knees.The knees swelled up and needed to be aspirated a few times as a result of the swelling(injection site joint swelling) (aspiration joint) (injection site joint effusion) (unknown onset and latency).Action taken: was not applicable.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: event assessed as medically significant a ptc (product technical complaint) was initiated on 21-apr-2023, for synvisc one (batch number and expiry date: unknown) with global ptc number 100322342.The sample was not received and the ptc stated: based on the complaint from intake team, there was no quality related defect that would pose as a malfunction.This complaint does not have a quality 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.Defect class has been updated to ii.The product lot number was not provided.A batch record review is 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 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) was required.(em (b)(6) 2023).The final investigation was completed on 16-may-2023 with summarized conclusion as no assessment possible.Additional information was received on 21-apr-2023 via quality department from other healthcare professional.Ptc details added; strength added.Text amended.Additional information was received on 16-may-2023.Ptc details was added.Text amended accordingly.Based on the previously received information, annex e codes were added in mir form.

• Brand Name: SYNVISC ONE
• 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: 16843704
• MDR Text Key: 314293002
• Report Number: 2246315-2023-00038
• 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: Physician Assistant
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• 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
• 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; Other
• Patient Sex: Female