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

Catalog Number 1082020

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

Patient Problems Synovitis (2094); Reaction (2414); Test Result (2695)

Event Date 12/03/2019

Event Type  Injury  

Event Description

Patient had bilateral durolane injections on (b)(6) 2019 (also had pneumonia vaccination on the same day).The left knee responded well but the right knee was presumed to have reactive synovitis.He traveled to (b)(6) over (b)(6) and then returned to the office on (b)(6) 2019.The physician aspirated over 100ml of fluid and sent off for analysis.Apparently, his wbc count was very high and they proceeded to the operating room to wash out the knee.At the time of reporting, the patient was in the hospital receiving iv antibiotics and no bacteria was growing in the culture.Initially, the physician indicated this may be a reaction to durolane itself.She was concerned an infection occurred during the actual procedure itself but since there is no bacteria growing, it is was presumed to be a reaction to the medication.Upon follow up with the physician on (b)(6) 2019, she does not believe that this event was due to the durolane but her assessment is pending final results of the effusion cultures.

• 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: 9506943
• MDR Text Key: 179811265
• Report Number: 3009595577-2019-00005
• 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
• Type of Report: Initial
• Report Date: 12/19/2019,12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1082020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2019
• Distributor Facility Aware Date: 12/05/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR