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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 Problems Patient-Device Incompatibility (2682); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Pain (1994); Inadequate Pain Relief (2388); Sleep Dysfunction (2517); Ambulation Difficulties (2544)
Event Date 01/01/2021
Event Type  Injury  
Event Description
I had durolane injection in right knee (b)(6) 2021 (not sure of day) for osteoarthritis. Had horrible pain few days later, continued into (b)(6). Went to dr and told him about this. He took x-ray and said everything looked the same as last x-ray. Suggested pain was from my back. Did not have pain before injection. Pain in calf was excruciating in (b)(6), went to primary dr and she ordered an ultrasound to make sure it was no a blood clot. Negative. It is now the middle of (b)(6) 2021 and i am in more pain than before injection. (knee & calf all the way to top of foot. I can not sleep, walk or socialize due to worsening of pain. I have heard from other people that they have experienced similar reaction. I dont think this is a good product. Are you aware of this side effect/ negative reaction? what, if anything can i do to get back to normal? normal being just knee pain.
 
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Brand NameDUROLANE
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
BIOVENTUS LLC
MDR Report Key12662575
MDR Text Key277664518
Report NumberMW5104745
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 Patient
Type of Report Initial
Report Date 10/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2021
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? 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: 10/18/2021 Patient Sequence Number: 1
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