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

Lot Number J808

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

Patient Problems Unspecified Infection (1930); Muscle Weakness (1967); Nausea (1970); Tachycardia (2095); Myalgia (2238); Shaking/Tremors (2515)

Event Date 11/24/1998

Event Type  Injury  

Event Description

Infection [infection nos].Became weak and shaky [weakness].Became weak and shaky [shaking].Nausea [nausea].Muscle aching [muscle ache].Felt rapid heart beat [heart rate increased].Synvisc 2 ml in right knee intraarticular as 1st injection for r.A.(rheumatoid arthritis) [off label use of device].Case narrative: this case is submitted following an incorrect worldwide id in case id ((b)(4)) which will be deleted.This report contains no new information.Initial information was received on 08-jan-2021 regarding an unsolicited valid serious case from a physician via health authorities of united states under reference mw5097840.This case involves an adult patient (gender: unknown) who experienced infection, became weak and shaky, nausea, muscle aching, felt rapid heart beat and after receiving hylan g-f 20, sodium hyaluronate (synvisc) 2 ml in right knee intraarticular as 1st injection for r.A.(rheumatoid arthritis) (off label use of device).The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.On an unknown date, the patient received synvisc (hylan g-f 20, sodium hyaluronate) at dose of 2 ml in right knee via intra-articular route as 1st injection for rheumatoid arthritis (considered as off label use of device; latency: same day) (lot - j808, expiration date: 01-sep-2000) (frequency: unknown).On (b)(6)1998, after unknown latency, the patient had infection, became weak (asthenia) and shaky (tremor), muscle aching (myalgia) and nausea, also felt rapid heart beat (heart rate increased) that lasted approximately 30 hours then subsided.The patient had no rash and local knee.These events were assessed as medically significant.Final diagnosis was felt rapid heart beat, muscle aching, nausea, became weak and shaky, infection and synvisc 2 ml in right knee intraarticular as 1st injection for r.A.(rheumatoid arthritis).Action taken: not applicable for off label use of device; unknown for rest all events it was not reported if the patient received a corrective treatment.The patient outcome is reported as recovered for felt rapid heart beat, not applicable for off label use of device; unknown for rest all events product technical complaint (ptc) was initiated with global ptc number (b)(4) on 08-jan-2021 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 (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: 22-jan-2021 and reopened follow up information was received on 11-jan-2021.Comet id number added.No significant information added.Additional information was received on 22-jan-2021 from healthcare professional.Global ptc results added.Text was amended accordingly.Follow up information was received on 25-feb-2021 from other healthcare professional.The complaint (b)(4) was reopened due to incomplete complaint information.No significant information was received.Follow up information was received on 24-mar-2021 from other healthcare professional.The complaint (b)(4) and (b)(4) were reopened due to incomplete complaint information.No significant information was received.

• 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: 11974138
• MDR Text Key: 255615432
• Report Number: 2246315-2018-00880
• 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: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2000
• Device Lot Number: J808
• 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