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

Lot Number BRSLO17A

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Experienced swelling and came back in for aspiration and checked for infection [joint effusion].Experienced swelling and came back in for aspiration and checked for infection [arthrocentesis].Experienced swelling and came back in for aspiration and checked for infection [joint swelling].Pseudosepsis [pseudosepsis].Case narrative: initial information received on 10-sep-2021 regarding an unsolicited valid serious case received from a other health professional from united states.This case is linked to cases (b)(4) and (b)(4).This case involves a (b)(6) year-old male patient who experienced swelling and came back in for aspiration and checked for infection, and pseudo sepsis 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 (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate, (formulation, dosage, b route, indication: unknown) (batch number: brslo17a).On the unknown date, after unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient experienced pseudo sepsis (pseudosepsis).Patient experienced swelling and came back in for aspiration and checked for infection, (joint effusion) (aspiration joint) (joint swelling).She had cultures which were negative and gradually resolved with anti-inflammatories.Action taken: unknown for all the events.Corrective treatment: anti-inflammatories for all the events.Outcome: recovered for all the events.

Event Description

Experienced swelling and came back in for aspiration and checked for infection [joint effusion].Experienced swelling and came back in for aspiration and checked for infection [arthrocentesis].Pseudosepsis [pseudosepsis].Experienced swelling and came back in for aspiration and checked for infection [joint swelling].Case narrative: initial information received on 10-sep-2021 regarding an unsolicited valid serious case received from a other health professional from united states.This case is linked to cases (b)(4) and (b)(4) (same patient).This case involves a 77-year-old male patient who experienced swelling and came back in for aspiration and checked for infection, and pseudo sepsis 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 (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate, (formulation, dosage, route, indication: unknown) injection liquid (solution) (strength: 48mg/ 6 ml) once (batch number: brsl017a).On the unknown date, after unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient experienced pseudo sepsis (pseudosepsis).Patient experienced swelling and came back in for aspiration and checked for infection, (joint effusion) (aspiration joint) (joint swelling).She had cultures which were negative and gradually resolved with anti-inflammatories.Action taken: not applicable for all the events.Corrective treatment: anti-inflammatories for all the events.Outcome: recovered for all the events.A product technical complaint (ptc) was initiated on 19-feb-2021 for synvisc one.Batch number: brsl017a; comet compliant id number: (b)(4).The production and quality control documentation for lot number brsl017a; expiration date (2024-03) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot number batch record review & lot number frequency analysis for lot number brsl017a no capa (corrective and preventive action) was required.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.This review had not indicated any safety issue.As of 21-sep-2021 there were 2 complaints on file for lot number brsl017 and all related sublots.2 complaints was on file for lot number: brsl017a: (2) adverse event reports final investigation complete date was 27-sep-2021.Sanofi would continue to monitor complaints as stated in sop (b)(4) "product event handling" to determine if a capa was required.Additional information received on 10-sep-2021 from other healthcare professional.Formulation, strength, global ptc number, frequency was added.Text amended accordingly.Additional information was received on 27-sep-2021 from the quality department.Ptc results were added.Text amended accordingly.

Event Description

Experienced swelling and came back in for aspiration and checked for infection [joint effusion] experienced swelling and came back in for aspiration and checked for infection [arthrocentesis] pseudosepsis [pseudosepsis] experienced swelling and came back in for aspiration and checked for infection [joint swelling] case narrative: initial information received on (b)(6) 2021 regarding an unsolicited valid serious case received from a other health professional from united states.This case is linked to cases (b)(6) and (b)(6) (same patient).This case involves a 77-year-old male patient who experienced swelling and came back in for aspiration and checked for infection, and pseudo sepsis 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 (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate, (formulation, dosage, route, indication: unknown) injection liquid (solution) (strength: 48mg/ 6 ml) once (batch number: brslo17a).On the unknown date, after unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient experienced pseudo sepsis (pseudosepsis).Patient experienced swelling and came back in for aspiration and checked for infection, (joint effusion) (aspiration joint) (joint swelling).She had cultures which were negative and gradually resolved with anti-inflammatories.Action taken: not applicable for all the events corrective treatment: anti-inflammatories for all the events.Outcome: recovered for all the events.Product technical complaint (ptc) was initiated with global ptc number (b)(4) on (b)(6) 2021 for product.Batch number; brsl017a; sample status: not available the investigation was in process additional information received on 10-sep-2021 from other healthcare professional.Formulation, strength, global ptc number, frequency was added.Text amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 12473932
• MDR Text Key: 271469358
• Report Number: 2246315-2021-00148
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: BRSLO17A
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention