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

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.

• Brand Name: MONOVISC 88MG/4ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): DEPUY MITEK / ANIKA THERAPEUTICS, INC.
• MDR Report Key: 12359836
• MDR Text Key: 268145515
• Report Number: MW5103464
• 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: 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 Received: 08/23/2021
• 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