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 Type  Injury  

Event Description

Case reference number (b)(4) is a spontaneous report sent on (b)(6) 2024 by an other health professional via sales representative, which refers to a 57-year-old male patient.Additional information was received on (b)(6) 2024 from the same reporter.No information about medical history, concomitant medication, history of allergies or previous similar treatments has been provided.On (b)(6) 2024, the patient received treatment with durolane to bilateral knees (unknown amount, lot number, injection technique and needle type).Two days after treatment, on (b)(6) 2024, the patient had developed a rash (injection site rash) on the lateral side of the left knee as well as complained of pain (injection site pain) and swelling (injection site swelling).The right knee had tolerated the injection.The patient did not go to the clinic until (b)(6)2024.At that time, the clinic staff thought it was bruise and treated it like a superficial hematoma and advised the patient to use a warm compress on the area.The patient did not take any medications for the event at that time.On (b)(6) 2024, the patient went to the emergency room (er) where the condition was confirmed to be nicolau syndrome (embolia cutis medicamentosa).The patient was treated with intravenous vancomycin [vancomycin] and ceftin [cefatrizine propyleneglycolate].The patient underwent a ct of the abdomen, which had normal findings and there was no sign of deep vein thrombosis (dvt).On (b)(6) 2024, the patient was discharged from the hospital and had currently gone to the (b)(6) to receive additional care.The patient received a debridement and will receive a skin graft over the area.Outcome at the time of the report: rash was unknown.Pain was unknown.Swelling was unknown.Nicolau syndrome was unknown.

Manufacturer Narrative

Company comment: the serious unexpected event of embolia cutis medicamentosa and the non-serious expected events of rash, pain and swelling at injection site were considered possibly related to the treatment.Seriousness criteria includes the need for multiple medical interventions, debridement and hospitalization to prevent permanent damage.Potential root cause includes the injection procedure.Potential contributory factor includes injection technique.The case meets the seriousness 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: 18818075
• MDR Text Key: 336738666
• Report Number: 9710154-2024-00012
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• 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
• Date Manufacturer Received: 02/06/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male