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U.S. Department of Health and Human Services

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

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BIOVENTUS DUROLANE ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Lot Number 18490
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Burning Sensation (2146); Injection Site Reaction (4562)
Event Type  Injury  
Event Description
Patient reported allergic reaction to durolane/ineffective, felt like fire upon injection.
 
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Brand NameDUROLANE
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
BIOVENTUS
MDR Report Key12384383
MDR Text Key268919323
Report NumberMW5103554
Device Sequence Number1
Product Code MOZ
UDI-Device Identifier89130202001
UDI-Public89130202001
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number18490
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 08/27/2021 Patient Sequence Number: 1
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