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

Lot Number 9RSP014A

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

Patient Problems Fever (1858); Headache (1880); Nausea (1970); Pain (1994); Chills (2191)

Event Date 08/25/2020

Event Type  Injury  

Event Description

Loss of appetite [appetite lost].Leg pains [leg pain].Developed a fever of 101.5 [fever].Headache [headache].Nausea [nausea].Chills [chills].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 12-jan-2021 regarding an unsolicited valid serious case from a patient via health authorities of united states under reference mw5098261 this case involves an adult patient (gender: unknown) who experienced loss of appetite, leg pains, developed a fever of 101.5, headache, nausea and chills, after receiving 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.Concomitant medications included losartan potassium (cozaar); cimetidine (tagamet); flecainide; fluticasone propionate (flonase); metformin (glucophage); metoprolol tartrate (metoprolol xl); lorazepam (ativan); rosuvastatin calcium (crestor); tramadol; estradiol (estradiol); asa; and vitamin d nos (vitamin d) in 2020, the patient received synvisc (hylan g-f 20, sodium hyaluronate) injection in left knee (lot - 9rsp014a; expiration date: 31-jul-2022) (dose, frequency, indication: unknown).On (b)(6) 2020, after unknown latency, the patient developed a fever of 101.5 (pyrexia), headache, nausea, chills, loss of appetite decreased appetite) and leg pains (pain in extremity).These symptoms lasted on and off treated with paracetamol (tylenol) prn (as needed) through 2020.These events were assessed as medically significant.Final diagnosis was chills, nausea, headache, developed a fever of 101.5, leg pains and loss of appetite.Action taken: no action taken for all the events the patient was treated with paracetamol (tylenol) for chills, headache, developed a fever of 101.5, leg pains, not reported for nausea and loss of appetite the patient outcome is reported as unknown for all the events a product technical complaint (ptc) was initiated on 28-jan-2021 for synvisc; batch number: 9rsp014a; global ptc number (b)(4).The production and quality control documentation for lot number 9rsp014a expiration date (2022-07) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot number batch record review & lot number frequency analysis for lot number 9rsp014a no capa is required.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.As of 02feb2021 there are (b)(4) complaints on file for lot number 9rsp014 and all related sublots: (b)(4) complaints are on file for lot number 9rsp014a: foreign matter, plunger issue, leakage, broken syringe, broken syringe prior, adverse events report and missing syringe.(b)(4) complaint is on file for lot number 9rsp014d: (b)(4) other (complaint nos).Sanofi will continue to monitor complaints as stated in sop (b)(4) 'product event handling' to determine if a capa is required.Final investigation was completed on 02-feb-2021.Follow up information received on 12-jan-2021 from other healthcare professional.Non-significant information follow up was received on 28-jan-2021 from healthcare professional.Global ptc number updated.Text amended accordingly.Additional information was received on 02-feb-2021 from other healthcare professional.Gptc results were received and added.Text was 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: 11974151
• MDR Text Key: 255628158
• Report Number: 2246315-2018-00885
• 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: 07/31/2022
• Device Lot Number: 9RSP014A
• 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