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

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

Event Date 11/06/2023

Event Type  Injury  

Event Description

Received injection of euflexxa in right knee.Developed severe pain and swelling in knee which has continued since the injection.I wasn't able to work due to pain with walking.Using motrin, tylenol, icing and elevating knee, methylprednisolone dose pack.Internet data said to contact doctor for severe pain and swelling which i did.Called ferring pharmaceuticals and they said they 8 out of 500 subjects developed this problem, but no data on how long the symptoms continued.Ferring pharmaceuticals.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
• MDR Report Key: 18173004
• MDR Text Key: 328689309
• Report Number: MW5148293
• 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: 11/15/2023

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: 11/17/2023
• Patient Sequence Number: 1
• Treatment: ALLEGRA. ; BABY ASA CHEWABLE.; CLONAZEPAM.; COQ-10 TRIPLE STRENGTH.; CRESTOR.; FISH OIL.; INTRAROSA PRASTERONE 6.5 MG.; METHYLPREDNISOLONE DOSE PACK.; MOTRIN. ; MVI WITHOUT IRON.; PEPCID.; PRESERVISION EYE VITAMINS.; PROTONIX.; REFRESH OMEGA 3 EYE DROPS.; RESTASIS EYE DROPS.; STOOL SOFTENER.; SYNTHROID. ; TYLENOL.; VIT D-3.
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White