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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Date 05/24/2022

Event Type  Injury  

Event Description

Monovisc injection for knee pain, did nothing to alleviate pain.I had cortisone treatments before that did alleviate pain.

• Brand Name: MONOVISC
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.
• MDR Report Key: 15192816
• MDR Text Key: 297614231
• Report Number: MW5111355
• 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: Patient
• Type of Report: Initial
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Hispanic
• Patient Race: American Indian Or Alaskan Native, Native Hawaiian Or Other Pacific Islander