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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK / ANIKA THERAPEUTICS, INC. MONOVISC 88MG/4ML ACID, HYALURONIC, INTRAARTICULAR

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DEPUY MITEK / ANIKA THERAPEUTICS, INC. MONOVISC 88MG/4ML ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Event Description
Knee surgery to repair and clean out meniscus in right knee. Patient is behind on therapy and hasn't had medication in over a year. Outpatient surgery.
 
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Brand NameMONOVISC 88MG/4ML
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
DEPUY MITEK / ANIKA THERAPEUTICS, INC.
MDR Report Key12359836
MDR Text Key268145515
Report NumberMW5103464
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 Unknown
Type of Report Initial
Report Date 08/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/23/2021
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

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