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

Lot Number UNKNOWN

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

Patient Problems Urticaria (2278); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Experienced hives on the side of his right knee and back [hives].He felt as if his throat would shut [throat discomfort].Case narrative: initial information received on 08-sep-2021 from (b)(6) regarding an unsolicited valid serious case received from a patient.This case involves an unknown age male patient who experienced hives on the side of his right knee and back and he felt as if his throat would shut with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate injection, dosage, frequency, route unknown (lot - unk) for arthritis in the knee.The information regarding lot number was requested.On an unknown date, post second injection, the patient experienced hives on the side of his right knee and back (urticaria), he stated he ended up going to the emergency room to seek treatment because he felt as if his throat would shut (oropharyngeal discomfort), he was prescribed steroids, he stated his doctor dismissed the possibility of an allergic reaction, the patient was afraid of receiving another injection and experiencing the same reaction but thought the product worked very well.These events were leading to intervention.Reportedly, when the patient received his first injection of 5 and it was wonderful.Action taken- not applicable.Corrective treatment: prescribed steroids.At time of reporting, the outcome was unknown for both events.

Event Description

Experienced hives on the side of his right knee and back [hives].He felt as if his throat would shut [throat discomfort].Case narrative: initial information received on 08-sep-2021 from united states regarding an unsolicited valid serious case received from a patient.This case involves an unknown age male patient who experienced hives on the side of his right knee and back and he felt as if his throat would shut with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate injection liquid (solution) (strength: 48mg/ 6ml), dosage, frequency, route unknown (lot - unk (unknown)) for arthritis in the knee.The information regarding lot number was requested.On an unknown date, post second injection, the patient experienced hives on the side of his right knee and back (urticaria), he stated he ended up going to the emergency room to seek treatment because he felt as if his throat would shut (oropharyngeal discomfort), he was prescribed steroids, he stated his doctor dismissed the possibility of an allergic reaction, the patient was afraid of receiving another injection and experiencing the same reaction but thought the product worked very well.These events were leading to intervention.Reportedly, when the patient received his first injection of 5 and it was wonderful.Action taken- not applicable.Corrective treatment: prescribed steroids.At time of reporting, the outcome was unknown for both events.Seriousness criteria: intervention required for both events.Product technical complaint (ptc) was initiated with global ptc number (b)(4) on (b)(6) 2021 for product.Batch number; unknown.Sample status: not available.The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa (corrective and preventive action) was required.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 ncr (non-conformance report) process.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 had not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required final investigation complete date: (b)(6) 2021 with summary code as no assessment possible.Additional information received on 08-sep-2021 from healthcare professional.Formulation, strength and global ptc number added.Text amended.Additional information was received on 20-sep-2021 from healthcare professional.Global ptc results were added.Text was amended accordingly.

Event Description

Experienced hives on the side of his right knee and back [hives] he felt as if his throat would shut [throat discomfort] case narrative: initial information received on 08-sep-2021 from canada regarding an unsolicited valid serious case received from a patient.This case involves an unknown age male patient who experienced hives on the side of his right knee and back and he felt as if his throat would shut with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate injection liquid (solution) (strength: 48mg/ 6ml), dosage, frequency, route unknown (lot - unk) for arthritis in the knee.The information regarding lot number was requested.On an unknown date, post second injection, the patient experienced hives on the side of his right knee and back (urticaria), he stated he ended up going to the emergency room to seek treatment because he felt as if his throat would shut (oropharyngeal discomfort), he was prescribed steroids, he stated his doctor dismissed the possibility of an allergic reaction, the patient was afraid of receiving another injection and experiencing the same reaction but thought the product worked very well.These events were leading to intervention.Reportedly, when the patient received his first injection of 5 and it was wonderful.Action taken- not applicable corrective treatment: prescribed steroids at time of reporting, the outcome was unknown for both events.Product technical complaint (ptc) was initiated with global ptc number 100156523 on 08-sep-2021 for product synvisc one.Batch number; unknown; sample status: not available the investigation was in process additional information received on 08-sep-2021 from healthcare professional.Formulation, strength and global ptc number added.Text amended.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 12473128
• MDR Text Key: 271455953
• Report Number: 2246315-2021-00146
• 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: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/24/2021

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: No Information
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2021
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/17/2021; 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention