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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOVENTUS LLC SODIUM HYALURONATE (DUROLANE) 60 MG/3ML ACID, HYALURONIC, INTRAARTICULAR

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BIOVENTUS LLC SODIUM HYALURONATE (DUROLANE) 60 MG/3ML ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Lot Number 18302
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Pain (1994); Inadequate Pain Relief (2388)
Event Date 02/12/2021
Event Type  malfunction  
Event Description
Two pts (one male, one female) had similar reactions to durolane viscosupplementation injection that were unexpected and uncommon. Patient #1 received 60 mg sodium hyaluronate injection in right knee on (b)(6) 2021. Patient returned to clinic on (b)(6) reporting worsening pain since injection. Patient #2 received 60 mg sodium hyaluronate injection in each knee also on (b)(6). Patient returned to clinic on (b)(6) with 0 minutes of relief since last injection and no improvement in symptoms. Appears medications were from the same lot. Suspect possible device malfunction due to unexpected absence of relief from symptoms for all three injections from same lot.
 
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Brand NameSODIUM HYALURONATE (DUROLANE) 60 MG/3ML
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
BIOVENTUS LLC
MDR Report Key11588416
MDR Text Key243142057
Report NumberMW5100356
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 02/26/2021
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received03/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number18302
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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