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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Malaise (2359); Heart Failure/Congestive Heart Failure (4446)

Event Type  Death  

Event Description

Patient wife reported pt passed away on (b)(6) 2021.Medications discontinued - euflexxa, vemlidy, tacrolimus.She stated he was not feeling well, lots of complications, heart failure.No additional information provided.Reported to (b)(6) by pt/caregiver.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS, INC / BIO-TECHNOLOGY GENERAL (ISRAEL), LTD.
• MDR Report Key: 12384285
• MDR Text Key: 268905306
• Report Number: MW5103547
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• 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: 07/22/2021

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 Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death