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U.S. Department of Health and Human Services

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

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ANIKA THERAPEUTICS, INC. ORTHOVISC ACID, HYALURONIC, INTRA ARTICULAR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Urinary Tract Infection (2120)
Event Date 11/25/2016
Event Type  Injury  
Event Description
Notified of recent hospitalization via insurance claims. Diagnosis for admission n39. 0 - urinary tract infection site not specified. Admit date: (b)(6) 2016, discharge date: (b)(6) 2016. Dose or amount: 30mg, frequency: weekly for 3 wk, route: 1a. Dates of use: (b)(6) 2016. Diagnosis or reason for use: m17. 0.
 
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Brand NameORTHOVISC
Type of DeviceACID, HYALURONIC, INTRA ARTICULAR
Manufacturer (Section D)
ANIKA THERAPEUTICS, INC.
MDR Report Key6185609
MDR Text Key62861191
Report NumberMW5066764
Device Sequence Number1
Product Code MOZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 12/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2016
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
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 12/12/2016 Patient Sequence Number: 1
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