MAUDE Adverse Event Report: GENZYME SYNVISC ONE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fainting (1847); Fever (1858); Nausea (1970); Pain (1994); Respiratory Distress (2045); Swelling (2091); Tachycardia (2095); Anxiety (2328); Discomfort (2330); Reaction (2414); Neck Pain (2433); Sweating (2444); Shaking/Tremors (2515); Ambulation Difficulties (2544); Blood Loss (2597); No Code Available (3191)

Event Date 11/11/2015

Event Type  Injury  

Event Description

Synvisc-one, i am writing to file a severe adverse reaction i had knee injection shots from the product synvisc one.I received 2 separate rounds of this injection and after reading hindsight about this injection of others who had adverse reactions similar to mine, i truly believe this product needs to be removed from the general public immediately.I realize i am the small percentage of those affected but the year of hell i went through after receiving these injections needs to be addressed before others are jeopardized.I received the 1st set of injections in both knees on (b)(6) 2015.Although the injection stung and i began bleeding on my right knee from the injection, i became extremely faint and had to lay on the table for almost a 1/2 hr.I was barely able to walk our of the doctor's office from the swelling and tenderness to the injection site.At first i just thought all the things to follow were just a fluke of maybe something else going on but after experiencing nearly identical reactions after the 2nd set of injections on (b)(6) 2016, i know for sure that this was no coincidence.Also, i want to point out that my injections were given in i shot in both instances rather than 3 separate shots one week apart.After the 2 set of injections i could barely walk for 3 days.The swelling and pain from the injection was terrible.I could barely bend my knee.These were just the beginning of the reactions i had these shots.After the 2nd set of injections ran their course and i am now about a year out from the (b)(6) 2016 injections, i am finally starting to feel my self again.So many medical bills incurred during the course of that year trying to figure out what was wrong.I consider myself healthy and would only see my family doctor once a year for a physical.I would rather deal with my knee discomfort than to ever experience those symptoms again.Although i thought the symptoms were farfetched as a result of the injections it was not until i began researching the negative feedback that i would find from other pts experiencing the same side effects after receiving the injections.I realize it may provide relief for many but for those of us that had no idea that it would have such an adverse effect is worth it to me to write and please ask this injection be pulled from the market immediately.It was almost completely debilitating and impacted me physically and mentally.Below i will list what i experienced during those 6 months after receiving the injections: extremely lethargic all the time, never wanted to go out or do anything (so unlike me).Felt a sensation of nervousness because i felt something was going to happen.Joint discomfort throughout my body, low grade fevers, continual serious respiratory issues ranged from extremely slow heart rate at night that it would wake me up/also experienced the extreme which was rapid heart rates to the extent that i thought i was having a heart attack.With the respiratory issue was chest discomfort, and a type of paralysis very difficult to explain.When this happened i would become extremely sweaty, shaky and nauseous.Complete loss of control over my body.Feeling of something terribly wrong and what i would equate to what a panic attack would be like.I immediately went to my doctor who took ekg's and told me everything was okay.After happening again, i admitted myself to the er when they once again did ekg and chest xrays.Still nothing.Finally sought out a cardiologist.Did stress test, echocardiogram and ekg and still nothing.Also forgot to mention shortness of breath.Very scattered and had a very difficult time concentrating, neck pain, shoulder discomfort which i sought physical therapy for after both injections, coughing attacks.I am (b)(6) and considered myself very healthy.I am (b)(6).Only med i take is synthroid, i am very active.Quantity: 1 injection."how was taken or used: injections into the knees." reason for use: alleviate pain and discomfort in the knees.See scanned pages.

• Brand Name: SYNVISC ONE
• Type of Device: SYNVISC ONE
• Manufacturer (Section D): GENZYME
• MDR Report Key: 6776991
• MDR Text Key: 82505092
• Report Number: MW5071464
• 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: 08/07/2017

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/07/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 53 YR
• Patient Weight: 55