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

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/12/2022

Event Type  Injury  

Manufacturer Narrative

Company comment: the serious event of deep vein thrombosis was considered unexpected but a causal relationship to the treatment cannot be ruled out.Seriousness criteria include the need for medical intervention to prevent permanent damage.The potential root cause is the treatment procedure.Alternative etiology includes the patient's medical history of peripheral vascular disease.The case meets the criteria for expedited reporting to the regulatory authorities.Product note: 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.Recommendation for corrective and preventative action: no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 12-aug-2022 by a physician via a company employee concerning a female patient of an unknown age.The patient's medical history included peripheral vascular disease.No information about history of allergies or previous similar treatments has been provided.On (b)(6) 2022, the patient received treatment with durolane to unknown location (unknown amount, lot number, injection technique and needle type).Three days after durolane injection, on (b)(6) 2022, the patient experienced dvt (deep vein thrombosis).The patient went to urgent care where she had an ultrasound.The patient was prescribed eliquis [apixaban] and went home on the same day.The reporter does not believe the incident was related to the use of durolane injection.As of (b)(6) 2022, the patient was improving.Outcome at the time of the report: dvt was recovering/resolving.Tracking list: v.0 initial.V.1 fu received on (b)(6) 2022 from the nurse practitioner: case was upgraded to serious.Medical history updated to peripheral vascular disease from vein issues.Outcome of the event, reporter causality, lab test and corrective treatment details were updated.

• Brand Name: DUROLANE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): Q-MED; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer (Section G): Q-MED; seminariegatan 21; uppsala, SE-75 228; SW SE-75228
• Manufacturer Contact: randy russell ; 2001 ross avenue; suite 1600; dallas, TX 75201
• MDR Report Key: 15473374
• MDR Text Key: 300558542
• Report Number: 9710154-2022-00061
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2022
• 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