MAUDE Adverse Event Report: SYNVISC1; ACID, HYALURONIC, INTRAARTICULAR

Patient Problems Pain (1994); Loss of Range of Motion (2032); Presyncope (4410)

Event Date 10/11/2023

Event Type  Injury  

Event Description

I had the synvisc one injection in both knees.This is the fourth time i've had synvisc one i have been sent this three once.I've never had any side effects.Any pain anything except for this time.After the injections in both knees of the symvisc three i felt like i couldn't get off the table.They said to get off the table and i collapsed they had to put me in a wheelchair and i thought i was going to faint, i could barely get home i stayed in the house and used ice for three days in an ice and heat.The pain was worse than before the injections.I had pain and it felt like the inside of my knee was going to explode on both sides of the right and the left since i had the shot in the right and the left i called three or four times to the doctors office and they said as long as it's getting better that sounds good and they told me synvisc one has a lot of material that they inject but i told him i've had it four times before and nothing ever happened like this.It's now going on three weeks and i'm still in pain although it i can straight bend my leg i can straighten it, but i have to be very careful when i walk so i don't twist the pain was excruciating.It was nothing like anything i had ever experienced before there was no redness or heat only pain and it felt like it was swollen but i could not tell, felt like the inside was going to push out to the outside.

• Brand Name: SYNVISC1
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• MDR Report Key: 18142253
• MDR Text Key: 328357503
• Report Number: MW5148155
• 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: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• 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: AMAIODARONE ; CALCIUM; KEFLEX ; OMEPRAZOLE ; ROSUVASTATIN ; THYROID MED; WARFARIN ; ZETIA
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 40 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White