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

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

Patient Problems Skin Infection (4544); Swelling/ Edema (4577)

Event Date 12/15/2023

Event Type  Injury  

Event Description

Case reference number (b)(4) is a spontaneous report sent on 04-jan-2024 by a female patient of an unknown age via sales representative concerning herself.Additional information was received on 05-jan-2024 from the patient herself.No information about medical history, concomitant medication, history of allergies or previous similar treatments has been provided.On (b)(6) -2023, the patient received treatment with durolane to knee joint (unknown amount, lot number, injection technique and needle type).Initially, the patient felt relief from the injection, and she did not notice the swelling.On (b)(6) 2023, the patient started experiencing swelling (injection site swelling) at knee joint.On (b)(6) 2023, the patient rested and took advil [ibuprofen] for the swelling.But when she got up, she could not move her knee from the swelling and pain (injection site pain).On (b)(6) 2023, the patient could not walk and decided to go to the emergency room (er).The physician at the hospital said it looked like her knee was infected (injection site infection).At the er, fluid was collected from her knee and the physician stated that it did not look good.On (b)(6) 2023, the patient was called into emergency surgery to have her knee drained.Blood work and cultures from the fluid were taken, but she did not know the results.The patient was still in pain, but was improving.Outcome at the time of the report: swelling was recovering/resolving.Pain was recovering/resolving.Infected was recovering/resolving.

Manufacturer Narrative

Company comment: the serious events of infection and swelling at injection site and the non-serious event of pain at the injection site were considered expected and possibly related to the treatment.Seriousness criteria includes the need for surgical intervention in form of drainage to prevent permanent damage.The potential root cause includes injection procedure associated with inadequate aseptic technique.The case meets the criteria for expedited reporting to the regulatory authorities.Evaluation text: routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure.Lot number was not reported, and the product could not be verified.The information in this case does not indicate a non-conforming product or malfunction.The performed investigations are therefore considered adequate, and no additional investigations will be conducted.Capa comment: no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.

• Brand Name: DUROLANE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): Q-MED AB; seminariegatan21; uppsala
• Manufacturer (Section G): Q-MED AB; seminariegatan21; uppsala, SE-75 228; SW SE-75228
• Manufacturer Contact: randy russell ; 2001 ross ave; suite 1600; dallas, TX 75201
• MDR Report Key: 18507172
• MDR Text Key: 332811057
• Report Number: 9710154-2024-00003
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P170007/S014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/12/2024

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/04/2024
• Initial Date FDA Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female