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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
Lot Number P13354A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Stroke/CVA (1770)
Event Date 07/15/2020
Event Type  Injury  
Event Description
Patient suffered a mini stroke.
 
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Brand NameEUFLEXXA
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
FERRING PHARMACEUTICALS INC.
MDR Report Key10295375
MDR Text Key199735099
Report NumberMW5095600
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
Type of Report Initial
Report Date 07/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/02/2020
Device Lot NumberP13354A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 07/17/2020 Patient Sequence Number: 1
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