MAUDE Adverse Event Report: BIOVENTUS LLC. DUROLANE; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); High Blood Pressure/ Hypertension (1908); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/07/2022

Event Type  Injury  

Event Description

Heart palpitations and significant and consistent increase to blood pressure of 15 to 20 points and unusually poor circulation in ball of foot and 3 toes on right foot.This continues even though it's been a month after my right knee injection.Durolane knee injection.Therapy still on-going.Reason for use: knee osteoarthritis.

• Brand Name: DUROLANE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC.
• MDR Report Key: 14374867
• MDR Text Key: 291632232
• Report Number: MW5109644
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 89130202001
• UDI-Public: 89130202001
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 03/09/2023
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/11/2022
• Patient Sequence Number: 1
• Treatment: AMLOPODIPHINE; LOSARTAN; METOPROLOL; VITAMIN C
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American