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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FERRING PHARMACEUTICALS, INC. EUFLEXXA 1 PERCENT SODIUM HYALURONATE ACID, HYALURONIC INTRAARTICULAR

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FERRING PHARMACEUTICALS, INC. EUFLEXXA 1 PERCENT SODIUM HYALURONATE ACID, HYALURONIC INTRAARTICULAR Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Arthritis (1723); Erythema (1840); Fever (1858); Headache (1880); Muscle Spasm(s) (1966); Nausea (1970); Pain (1994); Swelling (2091); Tissue Damage (2104); Cramp(s) (2193); Urinary Frequency (2275); Reaction (2414); Fungal Infection (2419); Sweating (2444); Shaking/Tremors (2515); Ambulation Difficulties (2544)
Event Date 11/04/2015
Event Type  Injury  
Event Description
Euflexxa gel shots, (b)(6) 2015, (b)(6). I am sorry this has taken me so long to respond to. The euflexxa gel shots literally destroyed my life from (b)(6) 2015 to (b)(6) 2016. My husband developed prostate cancer in 2016 and we have been dealing with that. I have had knee problems for years and was told that since i have had severe reactions to many medications i was not a good candidate for any knee operations. Three doctors told me that i could die on the table as a knee operation was risky for me. My knees had been steadily worsening and walking was extremely difficult. They recommended that i see a pain management doctor, who administered steroid shots in my knees. No trouble with them, but he said that i was only allowed so many steroid shots. After discussions with this doctor he recommended the euflexxa gel shots. The first shot was scheduled for (b)(6) 2015. Developed an area on half of my stomach that looked like sunburn, which lasted for 2 weeks and just faded away, with a fever of 100. 5, (my normal temperature is 97. 6). I developed sweating, shaking and headaches that developed that night. On (b)(6) 2015, i developed horrific pain in my neck and shoulders, with muscle swelling in the back of my neck that has settled in two areas and getting worse. I have severe muscle spasms and it is hard for me to move my neck which feels tight and hard to move. I cannot drive because i cannot turn my head. I am using ice on the back of my head. During this time ((b)(6) 2015), i had severe pain on the right side of my face. I was placed on zithromax for 10 days. I started using meloxicam (7. 5 mg. Twice daily), for the pain which calmed down quite a lot. I woke up with really bad stomach cramps and a strong feeling of nausea, which lasted for several days then i stopped the meloxicam and my stomach returned to normal in 6 days. Then i was given soma 3 (350) and it worked, but i cannot move my neck without severe pain. The pain management doctor said that i was experiencing a flu. On (b)(6) 2015 pain management doctor said that what i had was a flu and not the shot. He said that i should have the second shot because the shots have to be given in a series of 3 shots with 2 week intervals. Second shot given - that night i had a fever of 101. 5 with horrific pain in my shoulders, neck, head, ears, and teeth, and all of the pain that i experienced after the first shot. The pain and muscle spasms in my neck are extreme. If i move my head in the wrong direction i experience sharp pains. Since the first shot my temperatures ranged from 99. 3 to 101. 7. I have had horrific pain in my knees and legs, shoulder, neck (which i cannot move), ears, teeth, swollen muscles with muscle spasms, joints, back of my head with terrible headaches, frequent urination, pain in my back, hard to move my right arm with pain on the left side. My throat and tongue was red, sore, with white bumps in the back of my throat. Seemed to have settled on the right side. Basically my entire body had excruciating pain throughout from (b)(6) 2015 to (b)(6) 2016. I also took gabapentin and tylenol with codeine to manage my pain. When i wake it is usually from the pain. I have to hold my head when i stand or else the pain is extreme. And then i put my hands behind my neck to soften the pain when i walk. There are three areas swollen on my neck. I have had lymphedema from a bilateral mastectomy, that has been under control until this happened. Now i am struggling with that swelling as well. It has increased in my stomach, arms and legs and feet. When my family said that this was from the euflexxa gel shots, i called euflexxa's help line after the second shot and asked for help. They never called me back. We believe that these shots also contain poultry by-products, (which i am allergic to and the doctor was aware of this). He said that there was nothing in these shots that i was allergic to. How about the preservatives that this medication might have in them? on (b)(6) 2015 - doctor ordered blood work from lab corp. Appeared normal. On (b)(6) 2015 - doctor ordered ct scan of my neck - advanced radiology - there are some changes in my neck area but nothing alarming. It was extremely painful for me to get this test because of the pain. On (b)(6) 2015 - mri. On (b)(6)2015 - x-rays of my neck (c-spine). On (b)(6) 2015: appointment with the pain management doctor - he wanted to give me the third shot. I refused. I asked him for help. I couldn't continue to live on pain medications forever. He finally suggested that maybe i am allergic to euflexxa gel shots, after we told him what had happened and was still happening to me. I asked for help. He told us that he was going away for 6 weeks and i was to continue with the pain medications and if i wasn't better to call him. My husband then told him to help me now - how about a prednisone pack for ten days to help me now, not in 6 weeks. We got the prescription for the prednisone. By (b)(6) 2015, after taking the prednisone, i was 75 percent better. I had dropped the tylenol with codeine and just taking soma. We have never returned to the pain management doctor. Doctors are supposed to heal not hurt. After i took the prednisone, i improved but sleeping was still hard. My arthritis had increased dramatically during this time. My chest feels like it is racing and quite uncomfortable. I had headaches into (b)(6) 2016 with increased muscle spasms. We investigated the fact that it will take months for the gel to clear my system. My thanksgiving and christmas was ruined by the shots. It has been a nightmare. If only the doctors admitted that the shots could be the cause of my suffering i would not have gotten the second shots. I could have avoided all of the other doctors that were suggested to me to try to find out why i had such medical problems and avoided all of the tests to see what was causing the horrific reactions. No one would admit that euflexxa gel shots were the cause. My family researched the shots and found out that others had bad reactions. It is now (b)(6) 2016 and i am living day to day with headaches and muscle and joint pain that may never go away and it could have been avoided. Diflucan reaction (b)(6) 2018 horrific reaction. I took diflucan (fluconazole - generic name) (b)(6) 2018 after having fungus/yeast infection on my chest area and just below my stomach - (this was quite a large oval patch of red, raised area - it actually smelled), since (b)(6) 2017. I used topical cream fluocinonide until (b)(6) 2018 then my doctor wanted me to use nystatin - the infections got worse. I switched back to fluocinonide for a while then my doctor told me to use a medicated powder on the areas to keep it dry. It was still red, nasty looking. I asked my doctor for diflucan (which i used in 2013 successfully), to completely rid my body of the infections. On (b)(6) 2018 i took 1 diflucan, i had trouble that night walking then the next day i was showering and had trouble standing and getting out of the tub. I couldn't walk and had a fever of 102. 8 for 4 days. I had paralysis of both legs from the top of my thigh to and including my feet. I could move my feet when sitting but when i stood i couldn't stand, nor walk, my feet would not move. Very difficult time. I couldn't get to the bathroom either. I couldn't move to get to the scooter or use my canes. When i called my doctor, she felt that it could be the flu and to go tot he emergency room. I asked her if it was okay to do a prednisone pack, but she was concerned if i couldn't walk to go to the emergency room. Really big mistake. Twelve hours of waiting and the staff was indifferent about my care. They had me down for pain in my legs, not paralysis of my legs and they were treating me for blood clot. I should have taken the prednisone and screw the hospital-worse trip to, during and from that i have ever experienced. Horrific care - i laid in my urine on a gurney for over 4 hours. Nothing to eat or drink during 10 hours - never offered. The next day i started the prednisone pack and the next day i could walk with help. Today is 02/10/2018 and my husband bought me a wheelchair so none of us would have to go to the hospital again. I am walking with care. I refused the third shot after the horrific reactions to the first two shots. The doctor said that maybe my reactions was from the shots. He refused to help me until my husband forced him to give me a prednisone - pack. He was going away for 2 weeks and couldn't be bothered - the reaction i had to the first shot should have alarmed him enough to say - no more shots of euflexxa for me - but he didn't. I trusted him and took the second shot - because he assured me that the reaction i had was not euflexxa. I needed help and if it wasn't for my husband's insistance for help - i don't know what would have happened. The prednisone reduced my pain by 75 percent - but it took over 6 months to recover. I never went back to him! a dose of 2 ml - is injected into the affected knee - weekly intervals for 3 weeks. How was it taken or used: injection. Date the person first started taking or using the product: (b)(6) 2015. Date the person stopped taking or using the product: (b)(6) 2015. Did the problem return if the person started taking or using the product again: yes. (2nd injection). Why was the person using the product: bone on bone arthritic knees - cannot be operated on because of medication allergies. Cannot walk.
 
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Brand NameEUFLEXXA 1 PERCENT SODIUM HYALURONATE
Type of DeviceACID, HYALURONIC INTRAARTICULAR
Manufacturer (Section D)
FERRING PHARMACEUTICALS, INC.
MDR Report Key7340926
MDR Text Key102624206
Report NumberMW5075875
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 02/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
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: 03/14/2018 Patient Sequence Number: 1
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