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U.S. Department of Health and Human Services

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

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DEPUY MITEK / ANIKA THERAPEUTIC, INC. MONOVISC 88MG/4ML ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Output Problem (3005)
Patient Problem Pain (1994)
Event Type  Injury  
Event Description
Pt reported he is in pain due to delay with delivery to mdo. Pt also reported he was hospitalized. (b)(6).
 
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Brand NameMONOVISC 88MG/4ML
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
DEPUY MITEK / ANIKA THERAPEUTIC, INC.
MDR Report Key12348464
MDR Text Key267721999
Report NumberMW5103374
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 08/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2021
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? 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

Patient Treatment Data
Date Received: 08/19/2021 Patient Sequence Number: 1
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