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

Patient Problems Dyspnea (1816); Headache (1880); Nausea (1970); Vomiting (2144); Dizziness (2194); Malaise (2359)

Event Date 12/08/2023

Event Type  Injury  

Event Description

Patient called to report an adverse event involving euflexxa injections he received in both knees on (b)(6) 2023.Patient stated right away after the injections he was not feeling right and experienced headache, trouble breathing, dizziness, nausea, and a cracking sound in knees when walking.Patient is concerned about the side effects getting worse and how long they will last, and is apprehensive about getting the rest of his scheduled injections due to the side effects he's experiencing.Reference report: mw5149340.

• Brand Name: EUFLEXXA - RIGHT KNEE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS / BIO-TECHNOLOGY GENERAL (ISRAEL) LTD
• MDR Report Key: 18356647
• MDR Text Key: 330974894
• Report Number: MW5149339
• 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: 12/08/2023

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Sex: Male