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

• Type of Report: Initial
• Report Date: 05/21/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage