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U.S. Department of Health and Human Services

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

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BIOVENTUS LLC. DUROLANE ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
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.
 
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Brand NameDUROLANE
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
BIOVENTUS LLC.
MDR Report Key14374867
MDR Text Key291632232
Report NumberMW5109644
Device Sequence Number1
Product Code MOZ
UDI-Device Identifier89130202001
UDI-Public89130202001
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
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
Date FDA Received05/11/2022
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? No Answer provided

Patient Treatment Data
Date Received: 05/11/2022 Patient Sequence Number: 1
Treatment
AMLOPODIPHINE; LOSARTAN; METOPROLOL; VITAMIN C
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