MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC KNEE INJECTION; ACID, HYALURONIC, INTRAARTICULAR

Lot Number 9RSPO14A

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

Patient Problems Fever (1858); Headache (1880); Nausea (1970); Pain (1994); Chills (2191); Decreased Appetite (4569)

Event Date 08/25/2020

Event Type  Injury  

Event Description

Had synvisc injection in the left knee on (b)(6) 2020 at the (b)(6) center located at (b)(6) by dr.(b)(6).On (b)(6) 2020 i developed a fever of 101.5, headache, nausea, chills, loss of appetite, and leg pains.These symptoms lasted on and off treated with tylenol prn thru (b)(6) 2020.I had the same reaction when injected in the left knee with synvisc on (b)(6) 2020 with illness starting on (b)(6) 2020 with symptoms of fever of 101, headache, nausea, chills, loss of appetite, and leg pains.Symptoms lasted on and off treated with tylenol prn.The lot # for the synvisc administered on (b)(6) 2020 was 9rspo14a, exp 2022-07.The lot number for the synvisc administered on (b)(6) 2020 was 9rspo12a, exp 2022-05.

• Brand Name: SYNVISC KNEE INJECTION
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 10975703
• MDR Text Key: 220690564
• Report Number: MW5098261
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/06/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/31/2022
• Device Lot Number: 9RSPO14A
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 142