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

Patient Problems Headache (1880); Pain (1994); Unspecified Musculoskeletal problem (4535)

Event Date 08/15/2023

Event Type  Injury  

Event Description

Had an euflexxa injection in my left knee, the first of 3.That evening and for 3 1/2 days i experienced muscle and joint pain from head to toe.Could not function for 3 days, headache.Second injection slight aches and pains.Third injection was ok, but have lingering joint and muscle pain that seems to travel throughout my body.Reference report #mw5145807, #mw5145809.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS INC.
• MDR Report Key: 17772828
• MDR Text Key: 323906278
• Report Number: MW5145808
• 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: 09/14/2023

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: 09/18/2023
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN; LETROZOLE; LISINOPRIL
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White