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 Erythema (1840); Itching Sensation (1943); No Code Available (3191)

Event Type  Injury  

Event Description

Stroke in the left knee [unspecified disorder of knee joint].Very red face [red face].Itching on the face [pruritus facial].Case narrative: based on additional information received on 11-feb-2020, the case which initially assessed as non-serious now updated as serious due to addition of event stroke in the left knee (medically significant and intervention required) initial information received on 28-jan-2020 regarding an unsolicited valid serious case received from a patient from (b)(6).This case involves an unknown age female patient who experienced very red face and itching on the face, stroke in the left knee (latency unknown) while using medical device hylan g-f 20, sodium hyaluronate (synvisc one).Patient was having allergy to iodine.The patient's other past medical history, vaccination(s) and family history were not provided.Patient had a history of using hylan g-f 20, sodium hyaluronate (synvisc) (3 doses).On an unknown date, the patient was treated with hylan g-f 20, sodium hyaluronate (6 ml syringe), (formulation, dosage, frequency, route, lot: unknown) for unknown indication.Information on the batch number was requested.On an unknown date, after unknown latency, after the application of the product, she began to present itching on the face and very red face.Patient wanted to know if the product was produced with aviary components, and if yes what reactions she might come to present.It was also reported that the patient got angry online and nervous, asking at all times to talk to a doctor or nurse about the questioning.On an unknown date, after an unknown latency, patient presented a stroke in the left knee (medically significant and intervention required) ended up in the emergency room, where she received diprospan.However, doctors did nothing more.Patient further reported that she did not get along with the product and would not use it again because the product was very violent.The patient was very dissatisfied with the care of sac (call center), informed that she was treated with neglect by the attendant.Action taken: not applicable for all events corrective treatment: betamethasone dipropionate (diprospan) for stroke in the left knee; not reported for rest both events.Outcome: unknown for all events.A product technical complaint was initiated, and results were pending for the same.Additional information received on 11-feb-2020 from patient.Event of stroke in the left knee added with details.Case updated to serious.Clinical course updated and text amended accordingly.

Event Description

Stroke in the left knee [unspecified disorder of knee joint]; very red face [red face]; itching on the face [pruritus facial].Case narrative: based on additional information received on 11-feb-2020, the case which initially assessed as non-serious now updated as serious due to addition of event stroke in the left knee (medically significant and intervention required) initial information received on 28-jan-2020 regarding an unsolicited valid serious case received from a patient from brazil.This case involves an unknown age female patient who experienced very red face and itching on the face, stroke in the left knee (latency unknown) while using medical device hylan g-f 20, sodium hyaluronate (synvisc one).Patient was having allergy to iodine.The patient's other past medical history, vaccination(s) and family history were not provided.Patient had a history of using hylan g-f 20, sodium hyaluronate (synvisc) (3 doses).On an unknown date, the patient was treated with hylan g-f 20, sodium hyaluronate (6 ml syringe), (formulation, dosage, frequency, route, lot: unknown) for unknown indication.Information on the batch number was requested.On an unknown date, after unknown latency, after the application of the product, she began to present itching on the face and very red face.Patient wanted to know if the product was produced with aviary components, and if yes what reactions she might come to present.It was also reported that the patient got angry online and nervous, asking at all times to talk to a doctor or nurse about the questioning.On an unknown date, after an unknown latency, patient presented a stroke in the left knee (medically significant and intervention required) ended up in the emergency room, where she received diprospan.However, doctors did nothing more.Patient further reported that she did not get along with the product and would not use it again because the product was very violent.The patient was very dissatisfied with the care of sac (call center), informed that she was treated with neglect by the attendant.Action taken: not applicable for all events.Corrective treatment: betamethasone dipropionate (diprospan) for stroke in the left knee; not reported for rest both events.Outcome: unknown for all events.A product technical complaint (ptc) was initiated on 30-jan-2020 for synvisc one.Batch number: unknown; global ptc number: 100019861.The product lot number was not provided; therefore, a batch record review is not possible.Based on lack of information provided, no capa was required.It was the requirement to review all finished batch records for specification conformation 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 surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Investigation complete date: 01-mar-2020.Additional information received on 11-feb-2020 from patient.Event of stroke in the left knee added with details.Case updated to serious.Clinical course updated and text amended accordingly.Additional information was received on 01-mar-2020 from other healthcare professional (genzyme event management group).Global ptc number and its results were added.Clinical course updated.Text amended accordingly.Follow up information received on 03-mar-2020.No new information was received.Upon internal review, list of countries where device is distributed was added in eu/ca device form.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 9732155
• MDR Text Key: 196123168
• Report Number: 2246315-2020-00043
• 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: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention