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

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/28/2023

Event Type  Injury  

Event Description

When asked "since your last refill, have you been hospitalized or had any changes in your medications, allergies, or medical conditions?" per pt (exact pt quote including spelling): yes; ''was hospitalized due to fluid pill and potassium out of control".No further information able to be obtained.

• Brand Name: MONOVISC PFS 88MG/4ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.
• MDR Report Key: 16522357
• MDR Text Key: 311125978
• Report Number: MW5115639
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• 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: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Treatment: UNIDENTIFIED DRUG PRODUCT
• Patient Age: 80 YR
• Patient Sex: Male