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

Device Problem Use of Device Problem (1670)

Patient Problem Atrial Fibrillation (1729)

Event Type  Injury  

Event Description

Event: pt reported a hospital stay due to a-fib and now on eliquis.No further info provided.Inject 1 syringe intra-articularly to the left knee weekly for 3 weeks.

• Brand Name: EUFLEXXA 20MG/2ML (6=3 SYR)
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
• MDR Report Key: 16445383
• MDR Text Key: 310345666
• Report Number: MW5115215
• 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: 02/17/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2023
• Patient Sequence Number: 1
• Treatment: AMITRIPTYLINE TAB 10 MG; ELIQUIS TAB 5MG ; ESTRADIOL TAB 1MG; LOSARTAN POT TAB 25MG; MULTIPLE VIT TAB ; SYNTHROID TAB 25MCG; VITAMI D CAP 50000 UNIT; XANAX TAB 0.25MG; ZANAFLEX CAP 2 MG
• Patient Outcome(s): Hospitalization
• Patient Sex: Female