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

Model Number N/A

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

Patient Problems Necrosis (1971); Pain (1994); Rash (2033); Swelling/ Edema (4577)

Event Date 12/29/2023

Event Type  Injury  

Event Description

It was reported a patient injected with the durolane product experienced a rash on the lateral side of the left knee.The patient also had pain and swelling at the injection site.The symptoms began two days post injection.The patient had a follow up with the clinic a month after the injection and was treated for bruising at the injection site.The symptoms continued and the patient went to the emergency room.The patient was diagnosed with nicolau syndrome and admitted to the hospital.The patient underwent a debridement of the area and was prescribed vancomycin and ceftin.The current patient status is unknown and it was reported the patient will have an additional follow up procedure, a skin graft, which has not yet been completed.

• 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: 18816128
• MDR Text Key: 336657091
• Report Number: 3009595577-2024-00001
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/07/2024,02/06/2024

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
• Device Model Number: N/A
• 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: 02/06/2024
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/07/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male