MAUDE Adverse Event Report: FERRING PHARMACEUTICALS /BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. EUFLEXXA; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Swelling/ Edema (4577)

Event Date 02/25/2023

Event Type  Injury  

Event Description

I had injections of euflexxa into my knees last friday.My doctor knew i had an adverse reaction to synvisc, which also contains hyaluronic acid.My right knee, which became swollen the last time (i cancelled the second and third injections of synvisc) also became swollen the day after the injection.I am seeing my doctor this week and plan to ask him to aspirate my knee, which is more than twice its size.I have arthritis in my knees.Reference report mw5115356.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS /BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
• MDR Report Key: 16466986
• MDR Text Key: 310706041
• Report Number: MW5115355
• 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: 02/27/2023

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/01/2023
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White