MAUDE Adverse Event Report: DEPUY MITEK / ANIKA THERAPEUTICS, INC. MONOVISC ; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 02/19/2020

Event Type  Injury  

Event Description

Pt stated that he is in the hospital.

• Brand Name: MONOVISC
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): DEPUY MITEK / ANIKA THERAPEUTICS, INC.
• MDR Report Key: 9744626
• MDR Text Key: 180849967
• Report Number: MW5093206
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2020
• Patient Sequence Number: 1
• Patient Age: 74 YR