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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FERRING PHARMACEUTICALS INC. EUFLEXXA ACID, HYALURONIC, INTRAARTICULAR

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FERRING PHARMACEUTICALS INC. EUFLEXXA ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Arthralgia (2355); Swelling/ Edema (4577)
Event Date 10/04/2021
Event Type  Injury  
Event Description
I had a series of 3 weekly euflexxa injections. This caused my symptoms to worsen and my knee to swell. Also my tendons attaching to my knees are seriously inflamed. Six weeks later, i am unable to walk any distance or stand for very long without pain. I have pain all the time. Prior to the injection i did have some swelling, but i was able to hike 6 miles several times a week. Now i cannot even walk a mile and standing or normal household chores cause pain and serious swelling. Post knee surgery. Administered by surgeon and (b)(6).
 
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Brand NameEUFLEXXA
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
FERRING PHARMACEUTICALS INC.
MDR Report Key12908638
MDR Text Key281593025
Report NumberMW5105687
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 11/29/2021
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received11/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 11/30/2021 Patient Sequence Number: 1
Treatment
ARMOUR THYROID 30 MG DAILY ; CALCIUM
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