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

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Spontaneous call from md to report that approximately half of medication leaked out of pre-filled syringe prior to injection.No missed dose, md used their own supply.Ni adverse event reported.Unknown if products is available for return.No other information provided.Reported to (b)(6) by: health professional.

• Brand Name: SUPARTZ FX PFS
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS, LLC
• MDR Report Key: 9681885
• MDR Text Key: 178349738
• Report Number: MW5092834
• 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: 01/28/2020

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
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2020
• Patient Sequence Number: 1