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

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

Patient Problem Complaint, Ill-Defined (2331)

Event Date 11/28/2018

Event Type  No Answer Provided  

Event Description

Doctor has prescribed the medication to be injected into hip.Dates of use: (b)(6) 2018; diagonsis or reason for use: m16.12; is the product compounded? no; is the product over-the counter? no.

• Brand Name: MONOVISC INJ 88MG/4ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ANIKA THERAPEUTIC, INC.
• MDR Report Key: 8146672
• MDR Text Key: 130169966
• Report Number: MW5081966
• 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: 11/28/2018

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: 12/07/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR