MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. ORTHOVISC PFS 30 MG/2ML; ACID, HYALURONIC, INTRAARTICULAR

Patient Problem Insufficient Information (4580)

Event Date 02/20/2024

Event Type  Death  

Event Description

Per patient spouse (b)(6), reported patient deceased on (b)(6) 2024.The cause of death was not provided by the reporter.

• Brand Name: ORTHOVISC PFS 30 MG/2ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.
• MDR Report Key: 18940413
• MDR Text Key: 338128315
• Report Number: MW5152985
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 03/15/2024

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 87 YR
• Patient Sex: Male