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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC ORTHOVISC 15MG/ML

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ANIKA THERAPEUTICS, INC ORTHOVISC 15MG/ML Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Cancer (3262)
Event Date 04/26/2017
Event Type  Injury  
Event Description
Hospital stay (b)(6) 2017. The c49. 9- malignant neoplasm connective and soft tissue uns states found tumor in right thigh. Unsure of results. Prescriber information - (b)(6).
 
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Brand NameORTHOVISC 15MG/ML
Type of DeviceORTHOVISC 15MG/ML
Manufacturer (Section D)
ANIKA THERAPEUTICS, INC
MDR Report Key6540446
MDR Text Key74428472
Report NumberMW5069499
Device Sequence Number1
Product Code MOZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 05/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/01/2017
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?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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