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

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 10/11/2021

Event Type  Injury  

Event Description

Patient reported that she has surgery on the right knee on (b)(6) 2021 and is on naproxen, as needed patient declined to be transfer to the rph for clinical consultations but was encourage and advised to give (b)(6) a call if she wants to speak with the rph for any clinical consultations.This will be (b)(6) first fill for the patient.Md.(b)(6).

• Brand Name: ORTHOVISC 30MG/2ML SYR
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): DEPUY MITEK / ANIKA THERAPEUTICS, INC.
• MDR Report Key: 12813352
• MDR Text Key: 280872053
• Report Number: MW5105293
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: ETODOLAC
• Patient Outcome(s): Hospitalization
• Patient Age: 51 YR
• Patient Sex: Female