MAUDE Adverse Event Report: LIFECORE BIOMEDICAL LLC. EUFLEXXA; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling/ Edema (4577)

Event Date 05/19/2023

Event Type  Injury  

Event Description

Received 3 separate injections of euflexxa to my left knee for treatment.Experienced chronic pain & swelling after the second and third injections.To date i on 3 separate occasions i have to have large amounts of fluids removed my knee.After reviewing the biopsy report it was determined by my rheumatologist that the root cause is an allergy towards the euflexxa.I am now trying to tame the acute pain and recurring pain with prednisone.Knowing h that this type of reaction to the medicine can occur and how to treat it would be very helpful.Mistakenly diagnosed as gout.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): LIFECORE BIOMEDICAL LLC.
• MDR Report Key: 17010610
• MDR Text Key: 316152889
• Report Number: MW5117907
• 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: Unknown
• Type of Report: Initial
• Report Date: 05/24/2023

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: 05/25/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White