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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Pt reported being diagnosed with a malignant growth on her lung during a scan and that she will need surgery to remove it.Freq: inject 1 syringe into the right knee weekly for 3 weeks.

• Brand Name: EUFLEXXA 20 MG/2ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
• MDR Report Key: 18846112
• MDR Text Key: 337122068
• Report Number: MW5152334
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female