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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EUFLEXXA

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EUFLEXXA Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Chest Pain (1776); Headache (1880); High Blood Pressure/ Hypertension (1908)
Event Date 11/16/2015
Event Type  Injury  
Event Description
Euflexxa knee injection (b)(6) 2015, almost fainted, severe headache, bp increased, chest pain. Second euflexxa knee injection (b)(6) 2015, severe headache, bp increased, had to go to er. Continuing severe headache and blood pressure increase, i'm now on bp meds from my family doctor. Never had bp problems prior to injections. Severe headache from euflexxa caused bp increase. I'd like to know how long euflexxa will stay in my system causing me problems. Reason for use: left knee pain, meniscus tear. Event abated after use: no.
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Type of DeviceEUFLEXXA
MDR Report Key5381024
MDR Text Key36497235
Report NumberMW5059428
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 01/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2016
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: 01/14/2016 Patient Sequence Number: 1