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

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

Patient Problem Necrosis (1971)

Event Date 09/23/2023

Event Type  Injury  

Manufacturer Narrative

Company comment: the serious unexpected event of embolia cutis medicamentosa and the non-serious expected event of rash at injection site were considered possibly related to the treatment.Seriousness criteria includes medically significant event of embolia cutis medicamentosa which if left untreated can lead to permanent damage.Potential root cause is the injection procedure, and a more specific cause cannot be established based on the available information.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.Lot number was not reported, and the product could not be verified.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 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 06-oct-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 (b)(6) 2023, the patient received treatment with durolane to the knee joint (unknown amount, lot number, injection technique and needle type).Two days after treatment, on (b)(6) 2023, the patient had experienced a rash (injection site rash) in the area of the knee near where the injection was performed.The reaction was on the opposite side of the knee where the injection was performed.On (b)(6) 2023, the event was reviewed by the clinical specialist who confirmed that the patient has nicolau syndrome (embolia cutis medicamentosa).During the injection, no lidocaine was used on the patient.On 11-oct-2023, the patient has scheduled follow-up visit with hcp.Treatment for the adverse event was not reported.Outcome at the time of the report: rash was not recovered/not resolved/ongoing.Nicolau syndrome was not recovered/not resolved/ongoing.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 06-oct-2023 by a physician via a company employee, which refers to a 59-year-old patient of unknown gender.The medical history of the patient included mild oa.No information about concomitant medication, or history of allergies has been provided.The patient did not have any ha injections previously.On (b)(6) 2023, the patient received treatment with durolane to the knee joint using 22-gauge needle (unknown amount, lot number, injection technique).The ultrasound guidance was not used to administer the injection.During the injection, no lidocaine was used on the patient.Two days after treatment, on (b)(6) 2023, the patient experienced a rash (injection site rash) in the area of the knee near where the injection was performed.On (b)(6) 2023, the patient had a follow up visit.The reaction was on the opposite side of the knee where the injection was performed.On (b)(6) 2023, the hcp at dermatology performed debridement and sample was sent for cultures, but no results were provided.On (b)(6) 2023, additional information was received from the reporter.The patient still had persistent necrosis (injection site necrosis), numbness (injection site hypoaesthesia), and burning, pain (injection site pain).Outcome at the time of the report: rash was not recovered/not resolved/ongoing.Necrosis was not recovered/not resolved/ongoing.Numbness was not recovered/not resolved/ongoing.Burning, pain was not recovered/not resolved/ongoing.Tracking list: v.0 initial.V.1 fu received on 03-nov-2023 from the same reporter: events (necrosis, numbness, burning, pain) added.Patient demographics, medical history, suspect device injection date, needle type, corrective treatment and laboratory data were updated.

Manufacturer Narrative

Company comment: the serious expected event of necrosis at injection site, and the non-serious, expected events of rash and pain at injection site, and unexpected event of hypoaesthesia at injection site were considered possibly related to the treatment.Seriousness criteria includes the need for intervention with debridement to prevent permanent damage.Based on event review and patient picture, the importer's clinical specialist confirmed that it was nicolau syndrome, with which the manufacturer agrees.Potential root cause is the injection procedure, and a more specific cause cannot be established based on the available information.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.Lot number was not reported, and the product could not be verified.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 preventive actions are deemed necessary based on the outcome of the performed investigations.

• 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: 18056478
• MDR Text Key: 327178053
• Report Number: 9710154-2023-00077
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170007/S014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2023
• Initial Date FDA Received: 11/02/2023
• Supplement Dates Manufacturer Received: 11/03/2023
• Supplement Dates FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention; Other
• Patient Age: 59 YR