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

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 06/19/2018

Event Type  No Answer Provided  

Event Description

Doctor has prescribed monovisc for an injection into the pt's hip.

• Brand Name: MONOVISC INJ 88MG/4ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.
• MDR Report Key: 7637947
• MDR Text Key: 112459477
• Report Number: MW5078068
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 59676082001
• UDI-Public: 59676082001
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 06/25/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR