MAUDE Adverse Event Report: DEPUY MITEK / ANIKA THERAPEUTICS, INC. ORTHOVISC 30/2 MG/ML - MILLLIGRAMS PER MILLILITRES; ACID, HYALURONIC, INTRAARTICULAR

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

Patient Problems Arthritis (1723); Breast Cancer (1759)

Event Type  Injury  

Event Description

Member has reported was diagnosed with breast cancer.Will have surgery on monday "(b)(6) 2020".Event ongoing.Date of event not specified.Diagnosis for use: osteoarthritis.

• Brand Name: ORTHOVISC 30/2 MG/ML - MILLLIGRAMS PER MILLILITRES
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): DEPUY MITEK / ANIKA THERAPEUTICS, INC.
• MDR Report Key: 10656762
• MDR Text Key: 211029456
• Report Number: MW5097156
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 59676036001
• UDI-Public: 59676-0360-01
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/06/2020

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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR