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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 Interaction Problem (4001)
Patient Problem Discomfort (2330)
Event Date 10/12/2021
Event Type  Injury  
Event Description
Underwent routine knee injection for thinning cartilage. One week after first injection, fullness and discomfort of injection still persists. No mention in literature or drug website that this way happen. Future patients, especially active ones, should have expectations set appropriately that they may not be able to resume exercise more than a week later.
 
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Brand NameEUFLEXXA
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
FERRING PHARMACEUTICALS, INC.
MDR Report Key12638653
MDR Text Key276854739
Report NumberMW5104634
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 Patient
Type of Report Initial
Report Date 10/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2021
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? No Answer provided
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

Patient Treatment Data
Date Received: 10/14/2021 Patient Sequence Number: 1
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