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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FERRING PHARMACEUTICALS INC. EUFLEXXA 1% SODIUM HYALURONATE

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FERRING PHARMACEUTICALS INC. EUFLEXXA 1% SODIUM HYALURONATE Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Erythema (1840); Fatigue (1849); Inflammation (1932); Nausea (1970); Pain (1994); Swelling (2091); Tachycardia (2095); Arthralgia (2355); Ambulation Difficulties (2544)
Event Date 11/08/2017
Event Type  Injury  
Event Description
I received my last of three weekly injections of euflexxa in my left knee beginning (b)(6) 2017 and ending (b)(6) 2017. Each injection brought on multiple negative side effects. These side effects included: immediate swelling of the left calf muscle. Joint pain on the left side of my body, up to and including my left wrist and muscle ache in the left forearm. Inability to walk for 3-4 days following each injection due to severe knee pain. Nausea. Fatigue and flu-like symptoms. Extremely red face and facial puffiness approx 15 minutes post injection. Racing / pounding heartbeat approx 5-10 minutes post injection and persisting approx 1-2 hours. In summation, the injections have made me ill, and have reduced my ambulatory capacity. I did inform my physician after the first injection. I was not advised to discontinue the series of injections. Now i am advised that due to the injections, knee surgery cannot even be discussed for two and one-half months to three months due to increased risk on infection because of the injections. I remain totally disabled and will not allow myself to be subject to treatment with euflexxa, or similar injections in future. Thank you for collecting data on this medication type. Dates of use: (b)(6) 2017. "did the problem stop after the person reduced the dose or stopped taking or using the product: yes, did the problem return if the person started taking or using the product again: yes. Osteo arthritis left knee.
 
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Brand NameEUFLEXXA 1% SODIUM HYALURONATE
Type of DeviceEUFLEXXA 1% SODIUM HYALURONATE
Manufacturer (Section D)
FERRING PHARMACEUTICALS INC.
MDR Report Key7041028
MDR Text Key92527281
Report NumberMW5073407
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2017
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

Patient Treatment Data
Date Received: 11/16/2017 Patient Sequence Number: 1
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