MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. ORTHOVISC INJ 30MG/2ML; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Off-Label Use (1494)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/25/2019

Event Type  Injury  

Event Description

Spoke to (b)(6), medical assistant at dr's office.They are aware the orthovisc is normally dosed once weekly but they want this pt to be on every other week dosing.Dates of use: (b)(6) 2019 - present.

• Brand Name: ORTHOVISC INJ 30MG/2ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.
• MDR Report Key: 8473620
• MDR Text Key: 140732245
• Report Number: MW5085483
• Device Sequence Number: 0
• Product Code: MOZ
• 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: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: Yes
• 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: 60 YR