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

Catalog Number	1082020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	05/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This adverse event "skin necrosis after intraarticular ha injection" is also known as "nicolau syndrome" or "embolia cutis medicamentosa." the pathogenesis is unclear - vasospasm as a reaction to the injection or direct occlusion/embolization of vessels by the injected substance is discussed.Nicolau syndrome has also been observed with other injectables such as corticosteroids.
Event or Problem Description
The patient is a (b)(6) year old male and he was injected on (b)(6) 2019 using image guidance.He was injected superior laterally while in a lying position.The patient started experiencing pain almost immediately as he was driving home from having the injection.He felt the pain arterial medially, near proximal tibial - opposite to the injection site.Patient developed a mottled, red/purple skin abnormality that has progressed to cover a 5x3 inch area at the knee with ongoing pain.Physician suspected possible skin necrosis.The patient has a history of significant tibial cysts and a recent mri post durolane injection showed that one of the cysts looks to be "leaking into the soft tissue anteriorly".Treatment has included daily hyperbaric treatment, nitroglycerin, topical treatments (are treating like a chemical burn).The patient has been seen by dermatology and vascular specialists.Patient has since shown signs of improvement.

• Brand Name: DUROLANE
• Common Device Name: HYALURONIC ACID
• Manufacturer (Section D): Q-MED AB; seminariegatan 21 ; uppsala, SE-75 2 28; SW SE-752 28
• MDR Report Key: 8739461
• Report Number: 3009595577-2019-00002
• Device Sequence Number: 13825360
• Product Code: MOZ
• UDI-Device Identifier: 00816986020808
• UDI-Public: 00816986020808
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/06/2019
• Report Date (Section F): 06/07/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 1082020
• Device Lot Number: 16666
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/06/2019
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/07/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR