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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FERRING PHARMACEUTICALS INC. EULFEXXA ACID, HYALURONIC, INTRAARTICULAR

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FERRING PHARMACEUTICALS INC. EULFEXXA ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Lot Number P14216A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Information (3190)
Event Date 11/13/2019
Event Type  Injury  
Event Description
(b)(6) had a right knee replacement 2 days ago.
 
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Brand NameEULFEXXA
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
FERRING PHARMACEUTICALS INC.
MDR Report Key9354197
MDR Text Key167597464
Report NumberMW5091222
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 11/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date04/28/2020
Device Lot NumberP14216A
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: 11/20/2019 Patient Sequence Number: 1
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