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

Lot Number 18882

Patient Problem Breast Cancer (1759)

Event Type  Injury  

Event Description

The patient reports being diagnosed with stage 1 breast cancer since her last refill.No additional details documented.The following product information reflects the last dispense by alliancerx walgreens pharmacy (delivered 15 jun 2021) and was not provided by the primary reporter.

• Brand Name: DUROLANE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC.
• MDR Report Key: 18266946
• MDR Text Key: 329887956
• Report Number: MW5148760
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 89130202001
• UDI-Public: 89130-2020-01
• Combination Product (y/n): N
• 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: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 10/31/2023
• Device Lot Number: 18882
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female