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

Lot Number UNKNOWN

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

Patient Problems Arthralgia (2355); Joint Swelling (2356); Reaction, Injection Site (2442)

Event Type  Injury  

Event Description

Severe reaction to the injection, right knee became red, very swollen and was painful [injection site joint redness].Severe reaction to the injection, right knee became red, very swollen and was painful [injection site joint swelling].Severe reaction to the injection, right knee became red, very swollen and was painful [injection site joint pain].Case narrative: initial information received on 03-mar-2020 regarding a solicited valid serious case received from patient, in the scope of post-marketing sponsored study "(b)(6)".Patient id: unknown; country: (b)(6).Study title: (b)(6).This case involves elderly female patient who experienced severe reaction to the injection, right knee became red, very swollen and was painful, with the use of medical device 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 using hylan g-f 20, sodium hyaluronate, intra-articular injection at the dose of 2 ml, 3 times in right knee (lot - unknown) for osteoarthritis.On an unknown date, after unknown latency, patient had severe reaction to the injection.The knee became red, very swollen and was painful due to which patient ended up in emergency and was hospitalized for 4 days for the sane.Action taken: no action taken for all events.It was not reported if the patient received a corrective treatment.Outcome: recovered for all events.Product technical complaint (ptc) was initiated with global ptc number (b)(4) on 10-mar-2020 for product.Batch number; unknown device not returned.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 was 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 had not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required final investigation complete date: 13-mar-2020.Reporter causality: not reported for all events.Company causality: reportable for all events.Additional information was received on 13-mar-2020 from healthcare professional.Global ptc number and ptc results added.Text was amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• 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: 9853194
• MDR Text Key: 196442414
• Report Number: 2246315-2020-00047
• 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: foreign,health professional,s
• Type of Report: Initial
• Report Date: 03/17/2020

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 Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2020
• 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): Hospitalization; Required Intervention