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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EUFLEXXA ACID, HYALURONIC, INTRAARTICULAR

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EUFLEXXA ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Headache (1880); Memory Loss/Impairment (1958); Pain (1994); Rash (2033); Swelling (2091); Cramp(s) (2193); Reaction (2414); Lethargy (2560)
Event Date 10/08/2016
Event Type  Injury  
Event Description
I have been using synvisc with no problem, kept me working, insurance change, they wanted euflexxa. First injection severe stomach cramps, 2nd injection, anaphylactic reaction, fever, rash, severe lethargy, headache, swelling in all joints. Flu like symptoms, neck pain, memory problems, knees hurt worse. Didn't work and refused 3rd set of injections. Had trouble breathing. Reason for use: knee pain. How was it taken or used: intra-articular. 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.
 
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Brand NameEUFLEXXA
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
MDR Report Key6043148
MDR Text Key58053345
Report NumberMW5065512
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 10/17/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2016
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: 10/18/2016 Patient Sequence Number: 1
Treatment
ADDERALL; COQ10; EXCEDRIN MIGRAINE; FISH OIL; FOLIC ACID; LORTAB; LOSARTAN; MAGNESIUM; METHOCARBAMOL; MULTI VITAMIN; NAPROXEN; NIACIN; PANTOPRAZOLE; PREDNISONE; VITAMIN B12; VITAMIN C; VITAMIN D3; VITAMIN E; XANAX; ZYRTEC
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