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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FERRING PHARMACEUTICALS EUFLEXXA

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FERRING PHARMACEUTICALS EUFLEXXA Back to Search Results
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Pain (1994); Joint Swelling (2356); Inadequate Pain Relief (2388)
Event Date 03/09/2017
Event Type  Injury  
Event Description
After my first injection of euflexxa on (b)(6) 2017, i noticed more swelling in my knee after a few days. After the 2nd injection of euflexxa on (b)(6) 2017, the swelling in my knee was worse. After the third injection of euflexxa the swelling remained as bad as after the second injection, and the pain continued to be severe. The swelling began to go down after two weeks somewhat, and by (b)(6) 2017 the swelling was reduced by 75 percent. I used ice on my knee daily during the aforementioned time period to help reduce swelling of the tissue around the knee. I did not see where the injections helped me at all. In fact the injections made my knee pain worse, and did not help me in walking any better. Quantity: 1 injection, frequency: 3, intramuscular. Dates of use: (b)(6) 2017. Did the problem stop after the person reduced the dose or stopped taking or using the product: yes. Post surgical severe right knee pain and swelling.
 
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Brand NameEUFLEXXA
Type of DeviceEUFLEXXA
Manufacturer (Section D)
FERRING PHARMACEUTICALS
MDR Report Key6538027
MDR Text Key74292150
Report NumberMW5069479
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 04/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2017
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: 05/01/2017 Patient Sequence Number: 1
Treatment
B12; CALCIUM ; CYMBALTA 60 MG; FUROSEMIDE 20 MG; GUIAFENESEN 600 MG; LEVOTHYROXINE 50 MCG; LOSARTAN 100 MG; MAGNESIUM; MELATONIN 3 MG; NORTRIPTYLINE 50 MG; POTASSIUM KTABS 10 MEQ; SIMVASTATIN 10 MG; TIZANIDINE; TRAMADOL 50MG; TYLENOL 500 MG; VIT D
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