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

Patient Problems Erythema (1840); Pain (1994); Swelling/ Edema (4577)

Event Date 04/20/2024

Event Type  Injury  

Event Description

My doctor gave me the three shots of euflexxa.My knee turned very red and swollen and hot.I was in a lot of pain.Now my knee hurts worse than before i had the treatment.Reference reports: mw5154367, mw5154369.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING / BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
• MDR Report Key: 19204054
• MDR Text Key: 341433322
• Report Number: MW5154368
• 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: 04/24/2024

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2024
• Patient Sequence Number: 1
• Treatment: THYROID.; VITAMINS.
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 67 KG