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U.S. Department of Health and Human Services

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

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FERRING, PHARMACEUTICALS, INC. EUFLEXXA HYALURONIC ACID Back to Search Results
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.
 
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Brand NameEUFLEXXA
Type of DeviceHYALURONIC ACID
Manufacturer (Section D)
FERRING, PHARMACEUTICALS, INC.
MDR Report Key6587297
MDR Text Key75959404
Report NumberMW5069994
Device Sequence Number1
Product Code MOZ
Reporter Country CodeUS
Number of Events Reported1
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 Received05/22/2017
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

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