MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. EUFLEXXA; ACID, HYALURONIC, INTRAARTICULAR

Patient Problem Pain (1994)

Event Date 11/01/2023

Event Type  Injury  

Event Description

In (b)(6) 2023 i took 3 injections of euflexxa by a doctor into my knees.As i went thru the series of injections i found that other areas of my body would have soreness, my hips, legs, shoulders and especially my lower back.I talked to my doctor and he had no explanation for the soreness but to offer to perform surgery on my knees.Twelve weeks have past since the last injection and i am still trying to deal with the pain not only in my knees but in most of other areas of my body.Some days the pain is so high that i barely get thru my daily activities.I take ibuprofen for the pain but it only last for a few hours.My main purpose for reporting this problem is to find out if others have had similar reactions and to get ideas of other medication that may help with the pain.The pain in my knees is still very noticeable.My name is (b)(6).Thank you for any information you can share with me.Reference reports: mw5152903, mw5152904.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
• MDR Report Key: 18920624
• MDR Text Key: 337996252
• Report Number: MW5152902
• 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: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• 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: ALLERGY MED.; IBUPROFEN.; LISINOPRIL 20 MG 1 A DAY.
• Patient Outcome(s): Disability
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White