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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DUROLANE INJECTION ACID, HYALURONIC, INTRAARTICULAR

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DUROLANE INJECTION ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Inadequate Pain Relief (2388); Ambulation Difficulties (2544); Swelling/ Edema (4577)
Event Date 06/04/2021
Event Type  Injury  
Event Description
I had my first durolane gel shot in my right knee on (b)(6) 2020 with no side effects. It helped my pain. I had a 2nd durolane gel shot on (b)(6) 2021 in my right knee since pain was returning. On (b)(6) i woke up to a very swollen knee and i had trouble walking. The swelling continued with ice and ibuprofen. After 2 weeks, i called my knee surgeon who prescribed a course of prednisone which helped but still had some swelling and difficulty walking. He told me it was the arthritis in my knee causing the swelling. I saw sports medicine dr. And started physical therapy on (b)(6) x2 per week. Exercise is helping the swelling and now able to walk better. Unable to play tennis or exercise walk as i was doing before the second durolane gel shot. Was given in the surgeon's office, no package. Knee pain following medial and lateral meniscus.
 
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Brand NameDUROLANE INJECTION
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
MDR Report Key12203720
MDR Text Key263221435
Report NumberMW5102678
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
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2021
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: 07/20/2021 Patient Sequence Number: 1
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