• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOVENTUS LLC DUROLANE PFS ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDUROLANE PFS
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
BIOVENTUS LLC
MDR Report Key11693019
MDR Text Key246472814
Report NumberMW5100850
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received04/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

-
-