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

Patient Problems Extreme Exhaustion (1843); Headache (1880); Hyperthermia (1909); Nausea (1970); Pain (1994); Swelling/ Edema (4577)

Event Date 08/29/2023

Event Type  Injury  

Event Description

I received a gel shot called synvisc one in my right knee on (b)(6) 2023.In 48 hours my knee swelled tremendously and had unbearable pain.On (b)(6) 2023 my dr removed 90 cc of fluid from my knee and said i'm having a severe reaction.The fluid was sent to the lab and no infection was found.On (b)(6) 2023 i received another aspiration of 55 cc of fluid.It is now 30 days after the injection and my knee is still swollen, hot, painful, i'm nauseous, have headaches, exhausted, my dr will not remove any more fluid at this time because my knee is so agitated.He is not sure how long these side effects will take to get out of my system.He has scheduled an mri to see if i have any tissue damage.This product contains formaldehyde, not sure if that's what my body is fighting.30 days later, can't walk much, and still so sick.

• Brand Name: SYNVISC ONE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 17863110
• MDR Text Key: 324890057
• Report Number: MW5146469
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• 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: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: MULTIVITAMIN ; OMEPRAZOLE 20MG
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 108 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White