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

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  Death  

Event Description

Died [death nos].So sore that last time he had it [pain].Case narrative: initial information received on 27-jul-2021 from (b)(6) regarding an unsolicited valid serious case received from a patient wife.This case involves an unknown age male patient who experienced died and so sore that last time he had medical device hylan g-f 20, sodium hyaluronate (synvisc).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 and route, lot number unknown) for unknown indication.The patient received 3 synvisc injections and it was so sore (pain) that last time he had it and he never had it again.The patient died more than 10 years ago on an unknown date in 2011.This event was aassessed as medically significant and leading to death.It was unknown if an autopsy was done.The cause of death was reported as death nos.Action taken- unknown it was not reported if the patient received a corrective treatment for the events (so sore that last time he had it, died).At time of reporting, the outcome was unknown for the event so sore that last time he had it and was fatal for the event died.

Event Description

Died [death nos].So sore that last time he had it [pain] case narrative: initial information received on 27-jul-2021 from canada regarding an unsolicited valid serious case received from a patient wife.This case involves an unknown age male patient who experienced died and so sore that last time he had medical device hylan g-f 20, sodium hyaluronate (synvisc).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, formulation injection, liquid (solution), strength 48mg/6ml (dosage and route, lot number unknown) for unknown indication.The patient received 3 synvisc injections and it was so sore (pain) that last time he had it and he never had it again.The patient died more than 10 years ago on an unknown date in 2011.This event was assessed as medically significant and leading to death.It was unknown if an autopsy was done.The cause of death was reported as death nos.Action taken- unknown.It was not reported if the patient received a corrective treatment for the events (so sore that last time he had it, died).At time of reporting, the outcome was unknown for the event so sore that last time he had it and was fatal for the event died.A product technical complaint (ptc) was initiated on 27-jul-2021 for synvisc (lot number unknown) with global ptc number (b)(4).The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa is required.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 ncr 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 has not indicated any safety issue.Sanofi will continue to monitor adverse events as stated in to determine if a capa is required.Final investigation was completed on 12-aug-2021.Additional information was received on 12-aug-2021 from other healthcare professional.Ptc results received and processed.Strength and formulation added.Text amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 12255075
• MDR Text Key: 264393056
• Report Number: 2246315-2021-00133
• 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,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other