• 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
Catalog Number 1082020
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Necrosis (1971)
Event Date 10/24/2019
Event Type  Injury  
Manufacturer Narrative
The adverse event known as nicolau syndrome or embolia cutis medicamentosa with skin necrosis can occur following intra-articular ha injection. The pathogenesis of this reaction is unclear. Vasospasm as a reaction to the injection or direct occlusion/embolization of the vessels by the injected substance is discussed. A missed injection that damages the surrounding soft tissue rather than entering the intra-articular space could also be a contributing factor. Nicolau syndrome has also been observed with other injectables such as corticosteroids.
 
Event Description
The patient's knee was injected laterally with a 25 gauge needle on (b)(6) 2019 and she reported extreme pain, redness, warmth, and a burning sensation in the knee within 30 minutes of injection. It was also reported that the patient had skin discoloration/ecchymosis near the injection site, which was determined to be embolia cutis medicamentosa. There was no infection on (b)(6) 2019, the patient underwent arthroscopy with lateral release and joint wash out. Patient status was reported an improving. It is most likely that the injection missed the intra-articular space, involving the surrounding knee and soft tissue leading to nicolau syndrome and skin necrosis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDUROLANE
Type of DeviceHYALURONIC ACID
Manufacturer (Section D)
Q-MED AB
seminariegatan 21
uppsala, SE-75 2 28
SW SE-752 28,
MDR Report Key9366050
MDR Text Key179611483
Report Number3009595577-2019-00004
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 10/31/2019,11/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1082020
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/29/2019
Event Location Outpatient Treatment Facility
Date Report to Manufacturer10/31/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/22/2019 Patient Sequence Number: 1
-
-