MAUDE Adverse Event Report: SYNVISC

Device Problem Insufficient Information (3190)

Patient Problems Fatigue (1849); Pain (1994); Complaint, Ill-Defined (2331); Sweating (2444); Ambulation Difficulties (2544)

Event Date 01/06/2015

Event Type  Injury  

Event Description

I received synvisc knee injections on (b)(6) 2015 and have had extreme and significant increasing pain and intolerance to walking or event touching my knees.I assumed this was a normal progression of arthritis and was not going to benefit from synvisc.After reading online, other consumer adverse reports similar to my experience, i now realize that my high pain tolerance may have delayed my reporting to the fda and i should have reported this as an emergency situation to my physician.After the injection i became extremely fatigued to the point of nodding off to sleep while driving home from the doctor's office.I was barely able to pull off the highway and fell asleep for a short time.I then drove through a fast food establishment for fluids and food, then rested in a parking lot.I later attempted to drive home and periodically pulled over to rest before arriving home.After arrival, i iced and elevated my knees for 3 days.This was later reported to synvisc and i was told this has never been reported in the past (fatigue from injection).Thereafter when walking more than a few minutes i have broken out in a sweat and can only tolerate walking for a few minutes.The doctor's office and synvisc indicated it may take time for improvement after this injection.I feel that this medication has caused me significant medical issues and my delay in further treatment may have caused me severe permanent damage.

• Brand Name: SYNVISC
• Type of Device: SYNVISC
• MDR Report Key: 4739645
• MDR Text Key: 5707362
• Report Number: MW5042392
• Device Sequence Number: 1
• Product Code: MOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2015
• Patient Sequence Number: 1
• Treatment: RX MEDS: BENICAR; ELESTRIN; MOBIC SPIRONALACTONE; SULFASAZLINE; FOLIC ACID; SYNTHROID; ONE-A-DAY MULTIPLE VITAMIN; OTC MEDS: OSCAL 500
• Patient Outcome(s): Disability
• Patient Age: 58 YR
• Patient Weight: 82