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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK / ANIKA THERAPEUTICS, INC. MONOVISC (HYALURONATE SODIUM, STABILIZED) ACID, HYALURONIC, INTRAVASCULAR

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DEPUY MITEK / ANIKA THERAPEUTICS, INC. MONOVISC (HYALURONATE SODIUM, STABILIZED) ACID, HYALURONIC, INTRAVASCULAR Back to Search Results
Lot Number 0000004864
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem Insufficient Information (4580)
Event Date 04/21/2021
Event Type  malfunction  
Event Description
Monovisc (hyaluronate sodium, stabilized) injection for a patient was found to have white material floating in the syringe. Ndc 59676-0820-01 lot # 0000004864 manufact: depuy mitek.
 
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Brand NameMONOVISC (HYALURONATE SODIUM, STABILIZED)
Type of DeviceACID, HYALURONIC, INTRAVASCULAR
Manufacturer (Section D)
DEPUY MITEK / ANIKA THERAPEUTICS, INC.
MDR Report Key11752233
MDR Text Key248545231
Report NumberMW5101085
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 Pharmacist
Type of Report Initial
Report Date 04/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number0000004864
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

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