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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FERRING PHARMACEUTICALS INC. EUFLEXXA INJ 10MG/ML ACID, HYALURONIC, INTRAARTICULAR

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FERRING PHARMACEUTICALS INC. EUFLEXXA INJ 10MG/ML ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Inflammation (1932); Iritis (1940); Visual Disturbances (2140)
Event Date 11/26/2018
Event Type  Injury  
Event Description
Patient reports iritis flare up (which has led to visual disturbances) and knee pain and gum inflammation while on euflexxa. Dates of use: (b)(6) 2018; is the product compounded? no; is the product over the-counter?: no.
 
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Brand NameEUFLEXXA INJ 10MG/ML
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
FERRING PHARMACEUTICALS INC.
MDR Report Key8142400
MDR Text Key129887045
Report NumberMW5081948
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 Pharmacist
Type of Report Initial
Report Date 11/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/06/2018
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? Yes
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

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