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

Lot Number 21218

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Necrosis (1971)

Event Type  Injury  

Manufacturer Narrative

Company comment: the serious expected events of embolia cutis medicamentosa at injection site, and the non-serious expected event of oedema at injection site and the unexpected event of fibrosis at injection site were considered possibly related to the treatment.Seriousness criteria include medically significant events of embolia cutis medicamentosa and necrosis at injection site.Potential root cause includes treatment procedure associated with incorrect placement of needle/filler.The case meets the criteria for expedited reporting to the regulatory authorities.Evaluation text: routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure.The reported lot number was valid and verified the reported product.The information in the case does not indicate a non-conforming product or malfunction.The performed investigations are therefore considered adequate, and no additional investigations will be conducted.Capa comment: no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 04-aug-2023 by a physician via company employee which refers to a patient of an unknown age and gender.No information about medical history, concomitant medication, history of allergies or previous similar treatments has been provided.On an unknown date, the patient received treatment with durolane (lot 21218) to unknown location (unknown amount, injection technique and needle type).After treatment, the patient experienced tissue necrosis (injection site necrosis) and possible edema (injection site oedema)/fibrosis (injection site fibrosis) distal to the injection site of durolane.After referring to the previous mri, the reporting physician (radiologist) thought that the patient could possibly have nicolau syndrome (embolia cutis medicamentosa).Treatment for the adverse event was not reported.Outcome at the time of the report: nicolau syndrome was not recovered/not resolved/ongoing.Tissue necrosis was not recovered/not resolved/ongoing.Edema was not recovered/not resolved/ongoing.Fibrosis was not recovered/not resolved/ongoing.

Manufacturer Narrative

Company comment: the serious expected events of embolia cutis medicamentosa and necrosis at injection site, and the non-serious, expected events of oedema and atrophy at injection site and the unexpected event of fibrosis at injection site were considered possibly related to the treatment.Seriousness criteria include medically significant events of embolia cutis medicamentosa and necrosis at injection site.Potential root cause includes treatment procedure associated with incorrect placement of needle/filler.The case meets the criteria for expedited reporting to the regulatory authorities.Evaluation text: routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure.The reported lot number was valid and verified the reported product.The information in this case does not indicate a non-conforming product or malfunction.The performed investigations are therefore considered adequate, and no additional investigations will be conducted.Capa comment: no corrective or prentive actions are deemed necessary based on the outcome of the performed investigations.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 04-aug-2023 by a physician (radiologist) via company employee which refers to a patient of an unknown age and gender.No information about medical history, concomitant medication, history of allergies or previous similar treatments has been provided.On (b)(6) 2021, the patient had a baseline mri.On (b)(6) 2023, the patient received treatment with durolane (lot 21218) to both knees (unknown amount, injection technique and needle type) by physician.In 2023, the patient experienced tissue necrosis (injection site necrosis) and possible edema (injection site oedema)/fibrosis (injection site fibrosis) distal to the injection site of durolane.After referring to the previous mri, the reporting physician (radiologist) thought that the patient could possibly have nicolau syndrome (embolia cutis medicamentosa).On (b)(6) 2023, the injecting physician ordered to perform an x-ray and an ultrasound, but no results were provided.On (b)(6) 2023, the injecting physician had ordered mri scan.The reporting physician (radiologist) noted that the patient had atrophic changes (injection site atrophy) approximately 2 cm below the injections site.Treatment for the adverse event was not reported.Outcome at the time of the report: nicolau syndrome was not recovered/not resolved/ongoing.Tissue necrosis was not recovered/not resolved/ongoing.Edema was not recovered/not resolved/ongoing.Fibrosis was not recovered/not resolved/ongoing.Atrophic changes was unknown.Tracking list: v.0 initial v.1 fu received on 27-sep-2023 from same reporter.Event (injection site atrophy) added.Information regarding suspect device injection date, device location, and laboratory details were updated.

• Brand Name: DUROLANE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): Q-MED; seminariegatan 21; uppsala, SE752 28; SW SE75228
• Manufacturer (Section G): Q-MED; seminariegatan 21; uppsala, SE752 28; SW SE75228
• Manufacturer Contact: randy russell ; 2001 ross avenue; suite 1600; dallas, TX 75201
• MDR Report Key: 17666847
• MDR Text Key: 322476295
• Report Number: 9710154-2023-00064
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P170007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 21218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other