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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 Dyspnea (1816); Sore Throat (2396)
Event Type  Injury  
Event Description
On (b)(6) 2019 pt (b)(6) reports in june and present went to hosp er for trouble breathing. Pt reported having a sore throat for the past few months, has been through 2 rounds of amoxicillin, a round of prednisone. Diagnosis for use: osteoarthritis of knee.
 
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Brand NameEUFLEXXA
Type of DeviceACID, HYALURONIC INTRAARTICULAR
Manufacturer (Section D)
FERRING PHARMACEUTICALS INC.
MDR Report Key8901661
MDR Text Key154754402
Report NumberMW5089089
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 Other Health Care Professional
Type of Report Initial
Report Date 08/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2019
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
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 08/15/2019 Patient Sequence Number: 1
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