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

Lot Number 21478

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Spontaneous report.Nurse at doctor office reported that durolane syringe was defective.She reported that the tip of the syringe burst when examining medication.Missed dose, unknown if pt experienced any adverse events.Device not available.Indication: unilateral primary osteoarthritis, left knee.Reported to (b)(6) by health professional.

• Brand Name: DUROLANE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC.
• MDR Report Key: 18191818
• MDR Text Key: 328962399
• Report Number: MW5148363
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• 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: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 21478
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Male