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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOVENTUS, LLC DUROLANE ACID, HYALURONIC INTRARTICULAR

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BIOVENTUS, LLC DUROLANE ACID, HYALURONIC INTRARTICULAR Back to Search Results
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Headache (1880); Pain (1994); Inadequate Pain Relief (2388); Ambulation Difficulties (2544); Swelling/ Edema (4577)
Event Date 10/01/2021
Event Type  Injury  
Event Description
Reporter stated that she was injected in the knee with a durolane injection on (b)(6) 2021. After the injection she started having a headache that kept her up all night. She contacted the doctor's office the next day and was told to take tylenol. She stated she only got a temporary relief from the medication because the pain persist. She experienced pain that radiates to her hips, swelling in both knees that is more prominent on the right. It is difficult to ambulate, she has to drag her legs to walk. Her next appointment is on (b)(6) to speak with the doctor.
 
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Brand NameDUROLANE
Type of DeviceACID, HYALURONIC INTRARTICULAR
Manufacturer (Section D)
BIOVENTUS, LLC
MDR Report Key12689342
MDR Text Key278570121
Report NumberMW5104922
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 10/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
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

Patient Treatment Data
Date Received: 10/22/2021 Patient Sequence Number: 1
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