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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Edema (1820); Emotional Changes (1831); Pain (1994)

Event Date 10/21/2020

Event Type  Injury  

Event Description

After my euflexxa injection in tight knee the pain is excruciating.My knee burns, edema, developed such swelling fluid cysts developed deep in knee.Had torn meniscus remove year prior and was getting steroid injection which were helping.Dr recommended a better injection euflexxa for long relief.Well after the injection of euflexxa i can hardly walk.The pain so bad i want to end life at time cant sleep.The pain traveling into hip and low back from knee edema and pain.I thought this was supposed to provide longterm solution to steroids which were ok.This is affecting my job, what i do at home, i am now battling constant level 11 pain daily.Can't this stuff be drained from my knee.I am extremely upset and now worried about walking again.This is unacceptable to do this to anyone.Is there any solution to this severe pain and edema with severe mobility issues.Thank you.Please warn others about this what i consider nasty and debilitating medication.No stopped refused more injections.

• Brand Name: EUFLEXXA INJECTION FOR KNEE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS INC.
• MDR Report Key: 10831383
• MDR Text Key: 215989022
• Report Number: MW5097816
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• 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: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/12/2020
• Patient Sequence Number: 1
• Treatment: CALCIUM ; HYDROCORTISONE ; IBUPROFEN AS NEEDED; MAGNESIUM ; VIT C
• Patient Outcome(s): Disability
• Patient Age: 59 YR
• Patient Weight: 90