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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Arthralgia (2355); Swelling/ Edema (4577)

Event Date 10/04/2021

Event Type  Injury  

Event Description

I had a series of 3 weekly euflexxa injections.This caused my symptoms to worsen and my knee to swell.Also my tendons attaching to my knees are seriously inflamed.Six weeks later, i am unable to walk any distance or stand for very long without pain.I have pain all the time.Prior to the injection i did have some swelling, but i was able to hike 6 miles several times a week.Now i cannot even walk a mile and standing or normal household chores cause pain and serious swelling.Post knee surgery.Administered by surgeon and (b)(6).

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS INC.
• MDR Report Key: 12908638
• MDR Text Key: 281593025
• Report Number: MW5105687
• 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: 11/29/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: ARMOUR THYROID 30 MG DAILY ; CALCIUM
• Patient Outcome(s): Other; Disability
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White