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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOVENTUS LLC DUROLANE 60MG/3ML PFS INJ ACID, HYALURONIC, INTRAARTICULAR

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BIOVENTUS LLC DUROLANE 60MG/3ML PFS INJ ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Headache (1880); High Blood Pressure/ Hypertension (1908); Blurred Vision (2137); No Code Available (3191)
Event Date 06/12/2019
Event Type  Injury  
Event Description
Pt report high blood pressure and stay high for couple of days, slurred speech, blurred vision last for 2 hours, also headache that last about a week.
 
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Brand NameDUROLANE 60MG/3ML PFS INJ
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
BIOVENTUS LLC
MDR Report Key8712294
MDR Text Key148559454
Report NumberMW5087448
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 06/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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