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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FERRING USA EUFLEXXA HYALURONIC ACID

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FERRING USA EUFLEXXA HYALURONIC ACID Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Pain (1994); Arthralgia (2355); Joint Swelling (2356); Ambulation Difficulties (2544)
Event Date 08/17/2016
Event Type  Injury  
Event Description
I received three weekly lateral knee injections of euflexxa for joint pain. Four weeks later, i still have swollen, painful joints and legs. The pain keeps me awake all night, i have trouble walking up and down stairs, and i can't sit or stand for any length of time. I had synvisc injected two years ago and had none of these side effects. I am reporting this because i question the data i see online showing that euflexxa has fewer side effects than other forms of hyaluronic acids. There are many complaints from pts online in various forums that would suggest otherwise. I can't find any info about how to treat these side effects and i fear that there is no treatment. Date the person first started taking or using the product: (b)(6) 2016. Date the person stopped taking or using the product: (b)(6) 2016. Knee pain.
 
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Brand NameEUFLEXXA
Type of DeviceHYALURONIC ACID
Manufacturer (Section D)
FERRING USA
MDR Report Key5982951
MDR Text Key55930769
Report NumberMW5065057
Device Sequence Number1
Product Code MOZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2016
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? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 09/26/2016 Patient Sequence Number: 1
Treatment
BIOTIN; VIT D
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