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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 Patient-Device Incompatibility (2682)
Patient Problems Headache (1880); Itching Sensation (1943); Nausea (1970); Pain (1994); Arthralgia (2355); Alteration In Body Temperature (2682)
Event Date 03/24/2019
Event Type  Injury  
Event Description
Euflexxa injections; after first injection severe headache and chills lasting two days; after second injection, severe headache and chills lasting two days; after third injection - severe headache, chills, nausea, itching, and burning pain and throbbing in joints lasting two weeks; chills, itching, muscle pain continue. Knee replacement was too risky due to heart complications. Dr recommended knee injection with euflexxa.
 
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Brand NameEUFLEXXA
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
FERRING PHARMACEUTICALS, INC.
parsippany NJ
MDR Report Key8599780
MDR Text Key144827420
Report NumberMW5086523
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 Unknown
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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
Is This a Reprocessed and Reused Single-Use Device?

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