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

Lot Number T17556A

Patient Problems Erythema (1840); Unspecified Infection (1930)

Event Type  Injury  

Event Description

Pt reported an infection on the left knee but the right knee is having some issues, its progressing, was hospitalized on (b)(6) 2023, had red from knee to feet, it's still infected but getting better, they noticed the issues with the knees before but this is the first time with infection.Inject one prefilled syringe intra-articularly into right knee once a week for 3 weeks.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
• MDR Report Key: 18358212
• MDR Text Key: 330977341
• Report Number: MW5149363
• 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: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 09/19/2023
• Device Lot Number: T17556A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN TAB 40MG; BOSWELLIA POWDER SERRATA; CO Q-10 CAP 150MG; ENTRESTO TAB 24-26MG; FISH OIL CAP 1000MG; JARDIANCE TAB 25MG; METOPROLOL TAR TAB 50MG; RANOLAZINE TAB 500MG ER ; TURMERIC CAP 500MG
• Patient Outcome(s): Hospitalization
• Patient Sex: Male