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

Patient Problems Diarrhea (1811); Dyspnea (1816); Foreign Body Reaction (1868); Skin Tears (2516); Unspecified Respiratory Problem (4464)

Event Date 01/23/2024

Event Type  Injury  

Event Description

Euflexxa reaction severely dry right palm on skin of hand with several tiny tears.Runny nose and congestion.At times difficulty breathing.Diarrhea.Knee injection.

• Brand Name: EUFLEXXA INJECTION
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
• MDR Report Key: 18783558
• MDR Text Key: 336359210
• Report Number: MW5151997
• 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: 02/21/2024

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: 02/23/2024
• Patient Sequence Number: 1
• Treatment: PROBIOTIC.
• Patient Outcome(s): Disability
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Race: White