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

Patient Problem Insufficient Information (4580)

Event Date 04/25/2024

Event Type  malfunction  

Event Description

Spontaneous report.Insurance verification representative at mdo reported that the durolane medication leaked out of the pen, there was no seal or the seal was bad.Unknown if pt missed dose, if pt currently possesses defective device or if adverse event occurred.No further information provided.Reported to (b)(6) by: health professional.

• Brand Name: DUROLANE PFS
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC
• MDR Report Key: 19212631
• MDR Text Key: 341539485
• Report Number: MW5154428
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• 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: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2024
• Patient Sequence Number: 1
• Treatment: GENVOYA 150/150/200/10MG
• Patient Age: 61 YR
• Patient Sex: Male