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

Device Problems Human-Device Interface Problem (2949); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Spontaneous, patient wanted to know if md was supposed to remove excess fluid prior to injecting durolane.Informed her per package insert does say to remove excess joint effusion prior to injecting medication.Pt reported md did not do this and she doesn't feel the medication is working very well.Patient is going to follow up with md.No further dates, details or information were provided.No other information was reported during contact.All known information is contained on this form.Reported to (b)(6) by pt/caregiver.

• Brand Name: DUROLANE PFS
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC
• MDR Report Key: 11693019
• MDR Text Key: 246472814
• Report Number: MW5100850
• 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: 04/06/2021

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 Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2021
• Patient Sequence Number: 1