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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Pain (1994)

Event Date 09/23/2019

Event Type  Injury  

Event Description

Pt stated that the series of knee injections of orthovisc pfs 30mg/2ml didn't work and she still has pain in her right knee.

• Brand Name: ORTHOVISC INJ 30MG/2ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.
• MDR Report Key: 9543925
• MDR Text Key: 173743658
• Report Number: MW5092018
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• 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?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR