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

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.

• 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 Key: 9366050
• MDR Text Key: 179611483
• Report Number: 3009595577-2019-00004
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 11/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 1082020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/29/2019
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/31/2019
• 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