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

Model Number N/A

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 06/30/2022

Event Type  Injury  

Event Description

It was reported a patient who received a durolane injection in the knee to treat moderate osteoarthritis experienced a deep vein thrombosis blood clot.The patient had symptoms of pain in the calf, swelling and edema two days post injection.The patient went to the hospital emergently 4 days post injection and was given eloquis to treat a dvt blood clot in their calf.The patient made a full recovery and indicated the injection did work to alleviate their oa knee pain.

• 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: 15347125
• MDR Text Key: 299149083
• Report Number: 3009595577-2022-00002
• 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 Assistant
• Type of Report: Initial
• Report Date: 08/10/2022,08/09/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/09/2022
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/10/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 63 YR
• Patient Sex: Female