MAUDE Adverse Event Report: FERRING PHARMACEUTICALS INC./ BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. EUFLEXXA 20MG MILLIGRAM (S); ACID, HYALURONIC, INTRAARTICULAR

Lot Number U14997A

Patient Problem Pain (1994)

Event Type  Other  

Event Description

Pt reports that she has not seen any change and she still gets pain and she feels that the euflexxa is not working.

• Brand Name: EUFLEXXA 20MG MILLIGRAM (S)
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS INC./ BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
• MDR Report Key: 17425641
• MDR Text Key: 320149538
• Report Number: MW5120373
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Lot Number: U14997A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: ADVIL
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 95 KG