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

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event Description

Patient had inflammatory reaction (had an adverse reaction to durolane) md is switching patient to euflexxa, no more information directions; inject one syringe intra-particularly to bilateral knees one time at the physician¿s office.Indication: bilateral primary osteoarthritis of knee.Reported to (b)(6)/caremark by: patient/caregiver.

• Brand Name: DUROLANE PFS
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC
• MDR Report Key: 13026194
• MDR Text Key: 282605767
• Report Number: MW5106147
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• 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: 12/06/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/16/2021
• Patient Sequence Number: 1
• Patient Sex: Female