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

Model Number	1082020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medwatch report number received: mw5101728.
Event or Problem Description
It was reported a patient was hospitalized and required surgery to treat an infection following a durolane injection.Immediately following the injection, the patient developed pain and swelling.The patient was administered a cortisone shot which did not alleviate the patient's symptoms.Following the cortisone shot the physician confirmed a serious infection that required surgery and a month of antibiotics.The current patient status is unknown.Multiple attempts for additional information have been completed with no additional information received.

• Brand Name: DUROLANE
• Common Device Name: HYALURONIC ACID
• Manufacturer (Section D): Q-MED AB; seminariegatan 21; uppsala, SE-75 2 28; SW SE-752 28
• MDR Report Key: 12192280
• Report Number: 3009595577-2021-00002
• Device Sequence Number: 4440543
• Product Code: MOZ
• UDI-Device Identifier: 00816986020808
• UDI-Public: 00816986020808
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2021
• Report Date (Section F): 06/04/2021

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
• Operator of Device: Health Professional
• Device Model Number: 1082020
• Device Catalogue Number: 1082020
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/21/2021
• Date Report to Manufacturer: 06/23/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 54 YR
• Date Report Sent to FDA: 06/04/2021