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

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

Patient Problem Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

Pain and swelling that kept her from walking [unable to walk].Lot of pain [pain].Lot of pain and swelling [swelling].Case narrative: this case is linked to case (b)(4) (same patient).Initial information received on 08-jan-2021 regarding an unsolicited valid serious case received from health authorities of united states under reference mw5097714.This case involves a female patient who experienced pain and swelling that kept her from walking, while she was treated with hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date, the patient started taking injection series of hylan g-f 20, sodium hyaluronate 16mg/ 2ml, (dosage, indication, batch number, frequency: unknown) via intra-articular route.On an unknown date, after the unknown latency, patient experienced pain and swelling that kept her from walking (gait inability, pain and swelling).Events lasted for 2 weeks total.Final diagnosis was pain and swelling that kept her from walking.Action taken: not applicable for all the events.It was not reported if the patient received a corrective treatment.Outcome: recovered for all the events.A product technical complaint (ptc) was initiated on 08-jan-2021 for synvisc.Batch number: unknown; comet compliant id number: (b)(4).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa was required.It was 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 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 has not indicated any safety issue.Final investigation complete date was 28-jul-2021.No safety issues were indicated in this review.Seriousness criteria: medical significant for gait inability.Follow-up information was received on 08-jan-2021 from other healthcare professional.Global ptc number added.No significant information received.Additional information was received on 28-jul-2021 from the other healthcare professional.Ptc results added.Clinical course updated and text amended accordingly.

• Brand Name: SYNVISC
• 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: 12260125
• MDR Text Key: 266405597
• Report Number: 2246315-2021-00135
• 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
• Type of Report: Initial
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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): Other; Required Intervention