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

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 08/01/2020

Event Type  Death  

Event Description

Patient's brother reported that the patient passed away on (b)(6) 2020.

• Brand Name: DUROLANE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC
• MDR Report Key: 11831315
• MDR Text Key: 251152660
• Report Number: MW5101361
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 89130202001
• UDI-Public: 89130-2020-01
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 81 YR