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

Lot Number 9RSP012A

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

Patient Problems Fever (1858); Headache (1880); Nausea (1970); Pain (1994); Chills (2191); No Code Available (3191); Decreased Appetite (4569)

Event Date 08/25/2020

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated (b)(6) 2021: 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). Based on the available information, causal relationship between the events and suspect product could not be denied. However, further information regarding patient¿s medical history, past medications, concomitant medications, underlying conditions, and other risk factors would aid in better case assessment.

Event Description

Loss of appetite [appetite lost]. Leg pain [leg pain]. Chills [chills]. Headache [headache]. Nausea [nausea]. Fever 101. 5 [fever]. Case narrative: initial information was received on (b)(6) 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 - 9rspo12a; expiration date:31-may-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: unknown 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 with global ptc number (b)(4), and the results were pending for the same.

• 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: 11242224
• MDR Text Key: 229084394
• Report Number: 2246315-2021-00044
• 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: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Lot Number: 9RSP012A
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• 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 Treatment Data

Date Received: 01/28/2021 Patient Sequence Number: 1

Treatment

ASA (ASA), UNKNOWN.; ATIVAN (LORAZEPAM), UNKNOWN.; COZAAR (LOSARTAN POTASSIUM), UNKNOWN.; CRESTOR (ROSUVASTATIN CALCIUM), UNKNOWN.; ESTRADIOL (ESTRADIOL), VAGINAL CREAM.; FLECAINIDE (FLECAINIDE), UNKNOWN.; FLONASE [FLUTICASONE PROPIONATE], NASAL SPRAY.; GLUCOPHAGE [METFORMIN] (METFORMIN), UNKNOWN.; METOPROLOL XL (METOPROLOL TARTRATE), UNKNOWN.; TAGAMET [CIMETIDINE] (CIMETIDINE), UNKNOWN.; TRAMADOL (TRAMADOL), UNKNOWN.; VITAMIN D [VITAMIN D NOS], UNKNOWN.