MAUDE Adverse Event Report: FERRING PHARMACEUTICALS, INC. EUFLEXXA; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Discomfort (2330)

Event Date 10/12/2021

Event Type  Injury  

Event Description

Underwent routine knee injection for thinning cartilage.One week after first injection, fullness and discomfort of injection still persists.No mention in literature or drug website that this way happen.Future patients, especially active ones, should have expectations set appropriately that they may not be able to resume exercise more than a week later.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS, INC.
• MDR Report Key: 12638653
• MDR Text Key: 276854739
• Report Number: MW5104634
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• 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: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 34 YR
• Patient Weight: 83