Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: Q-MED AB DUROLANE; HYALURONIC ACID
  • 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
 

Q-MED AB DUROLANE; HYALURONIC ACID Back to Search Results
Model Number 1082020
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 02/09/2021
Event Type  Injury  
Manufacturer Narrative
Medwatch report number received: mw5101728.
 
Event Description
It was reported a patient was hospitalized and required surgery to treat an infection following a durolane injection.Immediately following the injection, the patient developed pain and swelling.The patient was administered a cortisone shot which did not alleviate the patient's symptoms.Following the cortisone shot the physician confirmed a serious infection that required surgery and a month of antibiotics.The current patient status is unknown.Multiple attempts for additional information have been completed with no additional information received.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DUROLANE
Type of Device
HYALURONIC ACID
Manufacturer (Section D)
Q-MED AB
seminariegatan 21
uppsala, SE-75 2 28
SW  SE-752 28
MDR Report Key12192280
MDR Text Key262418113
Report Number3009595577-2021-00002
Device Sequence Number1
Product Code MOZ
UDI-Device Identifier00816986020808
UDI-Public00816986020808
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/04/2021,06/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number1082020
Device Catalogue Number1082020
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/04/2021
Distributor Facility Aware Date06/21/2021
Date Report to Manufacturer06/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age54 YR
-
-