MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. ORTHOVISC INJ 15MG/ML; ACID HYALURONIC, INTRAARTICULAR

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 12/22/2018

Event Type  Injury  

Event Description

Pt called about the effectiveness of the orthovisc.He states that the orthovisc relieved 80% of his pain at first, but the pain later came back.He states that the percentage of the joint pain that was relieved progressively decreased over the course of the last 6 months.Dates of use: (b)(6) 2018.

• Brand Name: ORTHOVISC INJ 15MG/ML
• Type of Device: ACID HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.
• MDR Report Key: 8208405
• MDR Text Key: 132046300
• Report Number: MW5082716
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 59676036001
• UDI-Public: 59676036001
• 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: 12/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 49 YR