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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. ORTHOVISC ACID, HYALURONIC, INTRAARTICULAR

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ANIKA THERAPEUTICS, INC. ORTHOVISC ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Therapeutic Response, Decreased (2271)
Event Type  Injury  
Event Description
Lack of efficacy.
 
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Brand NameORTHOVISC
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
ANIKA THERAPEUTICS, INC.
MDR Report Key9317839
MDR Text Key166736719
Report NumberMW5091065
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 11/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? 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: 11/12/2019 Patient Sequence Number: 1
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