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

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.

• Brand Name: DUROLANE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS
• MDR Report Key: 12384383
• MDR Text Key: 268919323
• Report Number: MW5103554
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 89130202001
• UDI-Public: 89130202001
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 08/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/30/2023
• Device Lot Number: 18490
• Patient Sequence Number: 1
• Patient Outcome(s): Other