FDA Adverse Event Injury Summary report: N

SYNVISC GEL INJECTION

MDR report key: 19876518 · Received July 30, 2024

Report

Report Number
MW5157839
Event Type
Injury
Date Received
July 30, 2024
Date of Event
June 4, 2024
Report Date
July 25, 2024
Manufacturer
SANOFI-AVENTIS U.S. LLC
Product Code
MOZ
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MD, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

UPON THE RECOMMENDATION OF AN ORTHOPEDIC DOCTOR AND PHYSICIAN ASSISTANT (PA) I HAD A SYNVISC GEL INJECTION ADMINISTERED TO MY RIGHT KNEE FOR THE DIAGNOSIS OF OSTEOARTHRITIS. THE DAY OF MY GEL INJECTION MY KNEE WAS SWOLLEN, VERY WARM, RED, AND PAINFUL. THE PA NUMBED THE AREA AND ASPIRATED ABOUT 20 CC'S OF SYNOVIAL FLUID. SHE THEN ADMINISTERED 5 CC'S OF GEL. I WAS INSTRUCTED TO GO HOME AND REST. LESS THAN 24 HOURS LATER, MY KNEE WAS EXTREMELY SWOLLEN, VERY HOT, TENDER, PAIN WAS 8-10/10, AND I WAS UNABLE TO BEAR WEIGHT ON MY RIGHT LEG. I WAS FEELING ILL, WITH NAUSEA AND VOMITING, AND HAD A TEMPERATURE OF 100.8 DEGREES F, ORALLY. I CONTACTED THE ORTHOPEDIC OFFICE FOR ADVICE AND HELP. INITIALLY A STEROID TAPER PACK WAS PRESCRIBED WITH LITTLE RELIEF. A WEEK LATER A CORTISONE SHOT TO THE RIGHT KNEE WAS ADMINISTERED. THIS INJECTION WAS SOMEWHAT HELPFUL. NO OTHER TREATMENT WAS OFFERED. A PRESCRIPTION FOR PHYSICAL THERAPY AND AN MRI WAS PROVIDED. SUGGESTED I SEE A RHEUMATOLOGIST. A WEEK AFTER THE GEL INJECTION WAS ADMINISTERED THE SYNOVIAL FLUID SENT TO THE LAB WAS NOTED TO HAVE CALCIUM CRYSTALS PRESENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
885905 SYNVISC GEL INJECTION ACID, HYALURONIC, INTRAARTICULAR MOZ SANOFI-AVENTIS U.S. LLC

Patients

Seq Age Sex Outcome Treatment
1 65 YR Female Required Intervention| S CLOBETASOL PROPIONATE CREAM 0.05% TOPICAL.| FEXOFENADINE.| MAGNESIUM.| RED YEAST RICE.| TURMERIC.| VITAMIN B COMPLEX.| VITAMIN C.| VITAMIN D.| VITAMIN K.