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

Event Date 11/11/2021

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated (b)(6) 2021: this case concerns a patient who received treatment with hylan g-f 20, sodium hyaluronate but had amyotrophic lateral sclerosis later.Based on the lack of information, causal relationship of the device in the occurrence of events cannot be denied.However, further information regarding patient¿s concomitant medications and technique used while administration of injection precludes complete medical assessment of the case.

Event Description

Als (amyotrophic lateral sclerosis) [als].Case narrative: initial information received on 18-nov-2021 regarding an unsolicited valid serious case received from other health professional from united states.This case involves an unknown age and unknown gender patient who experienced als (amyotrophic lateral sclerosis) 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 solution for injection once (dose, route, strength, indication, batch number and expiry date: unknown).On (b)(6) 2021 patient was diagnosed with als (amyotrophic lateral sclerosis) (amyotrophic lateral sclerosis) (unknown latency) after starting use of hylan g-f 20, sodium hyaluronate.This event was assessed as medically significant.Action taken: not applicable.It was not reported if the patient received a corrective treatment for the event (als (amyotrophic lateral sclerosis)).At time of reporting, the outcome was unknown for the event als (amyotrophic lateral sclerosis).

Manufacturer Narrative

Sanofi company comment dated 26-nov-2021: this case concerns a patient who received treatment with hylan g-f 20, sodium hyaluronate but had amyotrophic lateral sclerosis later.Based on the lack of information, causal relationship of the device in the occurrence of events cannot be denied.However, further information regarding patient¿s concomitant medications and technique used while administration of injection precludes complete medical assessment of the case.

Event Description

Als (amyotrophic lateral sclerosis) [als].Case narrative: initial information received on 18-nov-2021 regarding an unsolicited valid serious case received from other health professional from united states.This case involves an unknown age and unknown gender patient who experienced als (amyotrophic lateral sclerosis) 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: 48 mg/ 6ml) (dose, route, strength, indication, batch number and expiry date: unknown).On (b)(6) 2021 patient was diagnosed with als (amyotrophic lateral sclerosis) (amyotrophic lateral sclerosis) (unknown latency) after starting use of hylan g-f 20, sodium hyaluronate.This event was assessed as medically significant.Action taken: not applicable.It was not reported if the patient received a corrective treatment for the event (als (amyotrophic lateral sclerosis)).At time of reporting, the outcome was unknown for the event als (amyotrophic lateral sclerosis).Additional information received on 18-nov-2021 from other healthcare professional.Global ptc number, form and strength were added.Text amended.

Event Description

Als (amyotrophic lateral sclerosis) [als] case narrative: initial information received on 18-nov-2021 regarding an unsolicited valid serious case received from other health professional from united states.This case involves an unknown age and unknown gender patient who experienced als (amyotrophic lateral sclerosis) 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: 48 mg/ 6ml) (dose, route, strength, indication, batch number and expiry date: unknown).On (b)(6) 2021 patient was diagnosed with als (amyotrophic lateral sclerosis) (amyotrophic lateral sclerosis) (unknown latency) after starting use of hylan g-f 20, sodium hyaluronate.This event was assessed as medically significant.Action taken: not applicable it was not reported if the patient received a corrective treatment for the event (als (amyotrophic lateral sclerosis)).At time of reporting, the outcome was unknown for the event als (amyotrophic lateral sclerosis).Product technical complaint (ptc) was initiated with (b)(4) on 18-nov-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: 17-dec-2021 with summary code as no assessment possible.Additional information received on 17-dec-2021 from other healthcare professional.Global ptc number, form and strength were added.Text amended.Additional information was received on 18-nov-2021 from healthcare professional.Global ptc results added.Text was amended accordingly.

• 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: 12879341
• MDR Text Key: 285985985
• Report Number: 2246315-2021-00177
• 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,Followup
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• 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