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 Type  Injury  

Event Description

Can't work/is disabled [impaired work ability] subjected to falling all the time [falling] is in pain [pain] does not sleep well because of it [sleep unwell] doesn't work as well for her because it takes a long time for all of the synvisc-one to go into her system and she is hurting still/instead of being 4 months before it gets painful, it is now painful at 3 months with no reported adverse event [therapeutic response shortened] doesn't work as well for her because it takes a long time for all of the synvisc-one to go into her system and she is hurting still with no reported adverse event [device effect incomplete].Case narrative: initial information was received from united states on 23-feb-2024 regarding an unsolicited valid case from a patient, this case became serious on 05-mar-2024.This case involves a 68 years old female patient who can't work/is disabled, subjected to falling all the time, is in pain, and does not sleep well because of it after the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].Also, it doesn't work as well for her because it takes a long time for all of the synvisc-one to go into her system and she is hurting still/instead of being 4 months before it gets painful, it is now painful at 3 months with no adverse event reported directly linked to this therapeutic response shortened and device effect incomplete.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On (b)(6) 2023, the patient received synvisc one (hylan g-f 20, sodium hyaluronate) (strength:48 mg/6ml) injection at dose of 1 dosage form once (batch number, expiry date, route, indication: unknown).The product was not used for the first time.There will be no information available on the batch number of this case as product was discarded.On an unknown date, after unknown latency, the patient was in pain (pain) and does not sleep well because of it (poor quality sleep).She said they switched her from synvisc to synvisc-one.She said the synvisc had been heaven for her.Her doctor suggested they try it so she can only have one injection so she agreed to it.But the problem was it did not work as well for her because it took a long time for all of the synvisc-one to go into her system, and she was hurting still (device effect incomplete).Instead of being 4 months before it gets painful, it was now painful at 3 months (therapeutic response shortened, onset date: feb-2024, latency: 3 months), and it was complicated for her because she was not planned for that.On an unknown date, after unknown latency, the patient was disabled.She could not work (impaired work ability, caused disability).She was subjected to falling all the time.Action taken: not applicable for pain, poor quality sleep, fall, and impaired work ability it was not reported if the patient received a corrective treatment for the events (pain, poor quality sleep, fall, and impaired work ability).At time of reporting, the outcome was not recovered for the event is in pain, was unknown for rest all the events a product technical complaint (ptc) was initiated on 23-feb-2024 for synvisc-one (lot/batch number: unknown) with global ptc number: (b)(4).The sample of the ptc was not available, and the ptc stated: preliminary assessment: based on the complaint from intake team, there is 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 has been updated to ii - (dp 26feb24).The product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa (corrective and preventive action) 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 (non-conformance) process.Sanofi will continue to monitor complaints and trending to determine if a capa is required.The final investigation was completed on 05-mar-2024 and the summarized conclusion was 'no assessment possible.' additional information was received on 23-feb-2024 from quality department via other healthcare professional: ptc number and details were added.Text was amended.Additional information was received on 05-mar-2024 from quality department via other healthcare professional: this case previously processed as non-serious was updated to serious with addition of event- can't work/is disabled (causing disability).Ptc details were received and added in the case.Events were added- can't work/is disabled and subjected to falling all the time.Clinical course was updated.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: 18877002
• MDR Text Key: 337407786
• Report Number: 2246315-2024-00019
• 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
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/11/2024
• 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): Disability
• Patient Sex: Female