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

Lot Number 6RSL047

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

Patient Problems Disability (2371); Fungal Infection (2419)

Event Type  Injury  

Event Description

Fungal infection in her knee [joint infection] ([cryptococcus antigen positive]) has been on crutches [walking aid user].Case narrative: initial information received on 11-sep-2018 regarding an unsolicited valid serious case received from a patient from united states.This case involves a (b)(6) years old female patient who received treatment with hylan g-f 20, sodium hyaluronate (synvisc one) and after unknown latency had experienced fungal infection in her knee and has been on crutches.The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.On an unknown date in (b)(6) 2017, the patient received intra-articular hylan g-f 20, sodium hyaluronate injection, 1 df, once, (lot - 6rsl047, 31-oct-2019) in left knee for knee osteoarthritis.On an unknown date, since the injection, patient was on crutches.On an unknown date, patient ended up going to the emergency room (er) and she was diagnosed with a fungal infection in her knee which was a cryptococcus infection.Patient was requesting compensation for this.Final diagnosis was has been on crutches and fungal infection in her knee.Corrective treatment was not reported for fungal infection in knee and crutches for walking aid user.The patient outcome is reported as not recovered for both events a pharmaceutical technical complaint (ptc) was initiated on 17-sep-2018 for synvisc one with global ptc number: (b)(4).The production and quality control documentation for lot 6rsl047 expiration date (2019-10-31) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot batch record review & lot frequency analysis for lot 6rsl047 no capa was required.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers and assessed 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.As of 17-sep-2018 there were 6 complaints on file for lot # 6rsl047: (4) tip breakages, (1) missing luer-lok hub and (1) adverse event report.Sanofi will continue to monitor complaints to determine if a capa is required.Seriousness criteria: medically significant for fungal infection in knee and disability for has been on crutches additional information was received on 17-sep-2018.Global ptc number and results were added.Text was amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer (Section G): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer Contact: darlene kadel ; 55 corporate drive, ms 55b-220; a; bridgewater, NJ 08807
• MDR Report Key: 8197081
• MDR Text Key: 131515292
• Report Number: 2246315-2018-00808
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/26/2018

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: No Information
• Device Expiration Date: 10/31/2019
• Device Lot Number: 6RSL047
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/26/2018
• 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; Disability