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 Loss of consciousness (2418)

Event Date 08/04/2022

Event Type  Injury  

Event Description

Had loc [loss of consciousness], acute onset vertigo [vertigo], abdominal discomfort [abdominal discomfort], went to vomit [vomiting], nausea [nausea].Case narrative: initial information received on 16-aug-2022 regarding an unsolicited valid serious case received from health authorities of australia under reference (b)(4).This case involves adult and unknown gender patient who experienced had loc, acute onset vertigo, abdominal discomfort, went to vomit and nausea 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, unknown dose, frequency, intra articular route (lot, expiration date and strength - unknown) for product used for unknown indication.The patient intra-articular injection, then that evening awoke from sleep with (date of onset: (b)(6) 2022, unknown latency for all the events) abdominal discomfort, nausea, went to vomit (vomiting) had loc (loss of consciousness; seriousness criteria: medically significant) then acute onset vertigo (vertigo).Has had bloods all normal and mri brain.Nothing to suggest infective cause.It is unknown if the patient experienced any additional symptoms/events.It is unknown if the patient had any medical history, concomitant disease or risk factor.It is unknown if there were lab data/results available.Relevant laboratory test results included: blood test - on an unknown date: [normal] magnetic resonance imaging head - on an unknown date: [no results.Nothing to suggest infective].Action taken: unknown for all the events.Corrective treatment: not reported for the events.Outcome: recovering / resolving for all the events.

Manufacturer Narrative

Sanofi company comment dated 07-sep-2022: this case involves a patient of unknown age and gender who had loss of consciousness, while being treated with medical device hylan g-f 20, sodium hyaluronate [synvisc] for product used for unknown indication.Based on the available information, causal relationship between the events and suspect product could not be established due to underlying condition being considered as the major factor for occurrence of events.However, further information regarding patient¿s medical history, past medications, concomitant medications, and other risk factors would aid in better case assessment.

Event Description

Had loc [loss of consciousness] acute onset vertigo [vertigo] abdominal discomfort [abdominal discomfort] went to vomit [vomiting] nausea [nausea] case narrative: initial information received on 01-sep-2022 regarding an unsolicited valid serious case received from health authorities of australia under reference (b)(4).This case involves adult and unknown gender patient who experienced had loc (loss of consciousness), acute onset vertigo, abdominal discomfort, went to vomit and nausea 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), concomitant disease, risk factors 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 via intra articular route (lot, expiration date, dose, frequency and indication: unknown).Information on batch number and expiry date requested.The patient had intra-articular injection, then that evening awoke from sleep with (date of onset: (b)(6) 2022, unknown latency for all the events) abdominal discomfort, nausea, went to vomit (vomiting) had loc (loss of consciousness; seriousness criteria: medically significant) then acute onset vertigo (vertigo).Has had bloods all normal and mri (magnetic resonance imaging) brain.Nothing to suggest infective cause.It was unknown if the patient experienced any additional symptoms/events.Relevant laboratory test results included: blood test - on an unknown date: [normal] magnetic resonance imaging head - on an unknown date: [no results.Nothing to suggest infective] action taken: not applicable for all the events.Corrective treatment: not reported for the events outcome: recovering for all the events.A product technical complaint (ptc) was initiated on 01-sep-2022 for synvisc-one (batch number and expiry date: unknown) with global ptc number: 100335385.The sample was not available.Ptc stated: complaint: adverse event preliminary assessment: based on the complaint from intake team, there was no quality related defect that would attribute to a malfunction 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.The defect class had been updated to ii.((b(6)).Investigation ((b(6)) the product lot number was not provided.A batch record review was 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 was identified and mitigated through the nonconforming material or product process.Sanofi would continue to monitor adverse events to determine if a capa (corrective and preventive action) was required.The final investigation for the ptc was completed on 20-jun-2023 with summarized conclusion as 'no assessment possible'.Follow up information was received on 01-sep-2022 from healthcare professional via quality department.Global ptc number added, strength added.No significant information received.Text amended.Additional information was received on 20-jun-2023 from quality department via other healthcare professional.Ptc results added.Text 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: 15386004
• MDR Text Key: 299558665
• Report Number: 2246315-2022-00109
• 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: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• 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