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 Pain (1994); Rash (2033); Blister (4537)

Event Date 10/14/2023

Event Type  Injury  

Event Description

It was reported by a physician, a patient injected with the durolane in their left knee, experienced red and purple rash on the medial side one day post injection.The patient also reported pain and blisters on the medial left side of the knee opposite of the injection.The patient did go to the emergency room and it is unknown if there was any treatment provided.The patient had a follow up visit with the injecting physician who prescribed steroids and antibiotics.The physician indicates the patient had no additional medical intervention and no cultures were taken.Three to four weeks post injection the patient is improving significantly.

• 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: 18246234
• MDR Text Key: 329482686
• Report Number: 3009595577-2023-00002
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 00816986020808
• UDI-Public: (01)00816986020808(17)251130(10)21368
• 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
• Type of Report: Initial
• Report Date: 11/01/2023,10/31/2023

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
• Device Lot Number: 21368
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/31/2023
• Event Location: Home
• Date Report to Manufacturer: 11/01/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Sex: Female