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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 Hypersensitivity/Allergic reaction (1907); Loss of consciousness (2418); Shaking/Tremors (2515); Confusion/ Disorientation (2553); Movement Disorder (4412)
Event Date 09/16/2021
Event Type  Injury  
Event Description
Euflexxa injection into the right knee. About three hours later, horrible bowel movement knees buckled, had to sit down, very shaky, talking to a friend who suggested i take blood pressure, too shaky to do so. A friend took me to er. I stayed overnight in er. Very disoriented. Could not verbalize my thoughts. Er thought i was having a stroke. I became unconscious. I called the orthopedic office and told them about how i was feeling after the injection. They said to call friday, september 17th if not better, i ended up in er and was not able to call them. Er doctor did. Orthopedic gave the drug by inject.
 
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Brand NameEUFLEXXA
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
FERRING PHARMACEUTICALS INC.
MDR Report Key12525473
MDR Text Key273389693
Report NumberMW5104173
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2021
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: 09/23/2021 Patient Sequence Number: 1
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