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 02/28/2020

Event Type  Injury  

Event Description

Verified orthovisc off-label use for injection into shoulder with (b)(6) at prescriber's office.

• Brand Name: ORTHOVISC INJ 30MG/2ML
• Type of Device: ACID HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.
• MDR Report Key: 9779697
• MDR Text Key: 182153787
• Report Number: MW5093473
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 59676036001
• UDI-Public: 59676036001
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• 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: 64 YR