MAUDE Adverse Event Report: BIOVENTUS LLC. DUROLANE 60 MG/3ML SYR (3=1); ACID, HYALURONIC, INTRAARTICULAR

Device Problem Use of Device Problem (1670)

Patient Problem Thrombosis/Thrombus (4440)

Event Type  Injury  

Event Description

The pt reports she had a blood clot a week after injection.Hospital told the pt.It had moved to her lungs as well.Per md (physician) medication was not the cause.The pt also mentioned history of breast cancer.The pt is not new to therapy but first time filling with arxwp (alliance rx walgreens pharmacy).Inject 1 syringe intraarticularly as directed.Inject 1 pre-filled syringe intraarticular into left and right knee once.

• Brand Name: DUROLANE 60 MG/3ML SYR (3=1)
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC.
• MDR Report Key: 17217730
• MDR Text Key: 318111211
• Report Number: MW5118869
• 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: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• 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
• Patient Sequence Number: 1
• Treatment: CLARITIN-D TAB 5-120MG; FASLODEX INJ 250/5ML ; IBRANCE TAB 125MG; VITAMIN D CAP 400UNIT; XARELTO TAB 20MG
• Patient Outcome(s): Hospitalization
• Patient Sex: Female