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

Device Problems Improper or Incorrect Procedure or Method (2017); Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Type  No Answer Provided  

Event Description

In response to an order for three injections of gelsyn-3 (bioventus) the pharmacy dispensed 2 boxes of gelsyn-3 and 1 of supartz fx (bioventus).Error was detected by prescriber's office prior to doing the ia injection.Product was replaced by pharmacy.(b)(6).

• Brand Name: SUPARTZ FX
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTIUS LLC
• MDR Report Key: 12226480
• MDR Text Key: 263858275
• Report Number: MW5102772
• Device Sequence Number: 1
• Product Code: MOZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1