MAUDE Adverse Event Report: BIOVENTUS LLC DUROLANE INJECTION; ACID, HYALURONIC, INTRAARTICULAR

Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling/ Edema (4577)

Event Date 03/14/2024

Event Type  Injury  

Event Description

Patient called to report an adverse reaction to a durolane injection she received on (b)(6) 2024.Patient stated she received the shot to help with knee pain, but after the shot her pain was worse and she experienced swelling and stiffness as well.

• Brand Name: DUROLANE INJECTION
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC
• MDR Report Key: 18986374
• MDR Text Key: 338777298
• Report Number: MW5153196
• 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: Patient
• Type of Report: Initial
• Report Date: 03/26/2024

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female