MAUDE Adverse Event Report: FERRING, PHARMACEUTICALS, INC. EUFLEXXA; HYALURONIC ACID

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Cramp(s) (2193); Arthralgia (2355); Ambulation Difficulties (2544)

Event Date 05/21/2017

Event Type  Injury  

Event Description

I have received 2 of 3 injections of the drug euflexxa - provided by my orthopedic surgeon.The injections were given in my left knee and i know that he injected properly.I dd not expect to get instant relief.However, the pain in my left knee has increased to a point where i can't walk without aid.There is terrible cramping in my calf down to the tips of my toes.I have also experienced joint pain (never before felt) in my hands and my lower back since receiving the 2nd injection.I had previously (6 months ago) received 3 injections of hyalgan which did not present any of the above mentioned effects.My physician recommended euflexxa based on "discussions with his associates" to possibly offer better resolution than hyalgan".I realize not all people suffer these side effects; however, this, to me, is extreme.That is why i am - for the first time in 65 years - offering comments to the fda.Please take them seriously.I will not accept the 3rd injection for fear of what may worsen in my system.Why was the person using the product: knee osteoarthritis.

• Brand Name: EUFLEXXA
• Type of Device: HYALURONIC ACID
• Manufacturer (Section D): FERRING, PHARMACEUTICALS, INC.
• MDR Report Key: 6587297
• MDR Text Key: 75959404
• Report Number: MW5069994
• 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: 05/21/2017

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: 05/22/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 87