MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. EUFLEXXA 20 MG/2ML (6=3 SYR); ACID, HYALURONIC, INTRAARTICULAR

Lot Number U17230A

Patient Problem Convulsion/Seizure (4406)

Event Date 11/20/2023

Event Type  Injury  

Event Description

Event: "patient's" wife reported that the patient experienced a brain bleed and had surgery for it on (b)(6) 2023.Two weeks later while at the doctors office getting the staples taken out of his head the patient experienced a seizure but his doctor told him that it was normal after the type of surgery he had.Inject 1 syringe intra-articularly into each knee weekly for 3 weeks.

• Brand Name: EUFLEXXA 20 MG/2ML (6=3 SYR)
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
• MDR Report Key: 18159758
• MDR Text Key: 328600639
• Report Number: MW5148244
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 55566410001
• UDI-Public: 55566410001
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/13/2023

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
• Device Lot Number: U17230A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2023
• Patient Sequence Number: 1
• Treatment: AMLODIPINE TAB 10MG.; ASPIRIN CHW 81MG.; ATORVASTATIN TAB 40MG.; AZEUFLUTIC SPR 137-50.; CIALIS TAB 5MG.; DYAZIDE CAP 37.5-25.; EFFIENT TAB 10MG.; ELIQUIS TAB 2.5MG.; FIBER TAB 625MG.; FLUTICASONE SPR 50MCG.; GLUCOS/CHOND TAB 500-400.; LEVOTHYROXIN TAB 150MCG.; METOPROL TAR TAB 25MG.; MONTELUKAST TAB 10MG.; MULTI-VITAMIN TAB.; NUCALA INJ 100MG.; POT CL MICRO TAB 20MEQ ER. ; SPIRIVA CAP HANDIHLR.; SYMBICORT AER 160-4.5.; TAMSULOSIN CAP 0.4MG.; TRELEGY AER 200MCG.; TRIAMT/HCTZ TAB 37.5-25.; VENTOLIN HFA AER.; VITAMIN B12 TAB 100MCG.
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Sex: Male