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 Problem Rash (2033)

Event Date 10/06/2023

Event Type  Injury  

Event Description

It was reported by the physician a patient injected with the durolane product developed a rash 2 days post injection.The rash appeared near the injection site on the opposite side of the knee.A clinical reveiw of the event identified possible nicolau syndrome.The patient did not have additional medical intervention.The current paitent status is unknown.

Event Description

Updated information was received.The patient had thier initial injection on (b)(6)2023 with a 22 gauge needle, ultrasound guidance was not used.The physician reported the following additional symptoms; persistent necrosis, numbness, burning sensation and pain.The patient had a debridement procedure completed where cultures were taken, no results or additional information was provided.

• 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: 18055762
• MDR Text Key: 327168037
• Report Number: 3009595577-2023-00001
• 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: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 10/10/2023,11/04/2023

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
• 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: 10/06/2023
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/10/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR