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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Numbness (2415); Ambulation Difficulties (2544)

Event Date 01/01/2021

Event Type  Injury  

Event Description

Leg pain [leg pain].Numbness [numbness].Headache [headache].Case narrative: initial information received on 17-nov-2021 from united states regarding an unsolicited valid serious case received from a sales representative.This case involves adult female patient who experienced leg pain, numbness and headache 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 (b)(6) -2021, the patient started using hylan g-f 20, sodium hyaluronate, (solution for injection) (strength: 48 mg/ ml) (route, indication, frequency, dose: unknown) in the left knee.On the unknown date of 2021, after the unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient experienced leg pain (pain in extremity), numbness (hypoaesthesia) and headache.On (b)(6) 2021, patient received steroid injection.Action taken: not applicable for all the events.Corrective treatment: not reported for headache; steroid for numbness and leg pain.Outcome: unknown for all the events.Seriousness criteria: intervention required (steroid) for numbness and leg pain.Product technical complaint (ptc) was initiated with global ptc number (b)(4) on 17-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: 01-dec-2021 with summary code as no assessment possible.Additional information was received on 17-nov-2021 from the quality department.Global ptc number added.Formulation and strength added.Text amended accordingly.Additional information was received on 01-dec-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: 12959256
• MDR Text Key: 287258891
• Report Number: 2246315-2021-00178
• 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: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• 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
• Patient Sex: Female