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

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

Pt report that he had gotten a durolane injection from the mdo office and needs to replace it, but pt had reaction after getting the injection.Pt stated that his knee locked up and the whole knee started to swell which caused a lot of pain.Pt had to go to the er and get durolane sucked removed.Pt has not received first dose from arxwp.Inject 1 syringe intra-articularly into the affected knee.

• Brand Name: DUROLANE 60 MG/3ML SYR (3=1)
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC.
• MDR Report Key: 17842660
• MDR Text Key: 324701190
• Report Number: MW5146285
• 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: 09/26/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male