MAUDE Adverse Event Report: FERRING PHARMACEUTICALS INC. EUFLEXXA; ACID, HYALURONIC, INTRAARTICULAR

Lot Number NOT REPORTED

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

Patient Problem Insufficient Information (4580)

Event Date 06/06/2021

Event Type  Death  

Event Description

Patient's husband reported that patient passed away on (b)(6) 2021.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS INC.
• MDR Report Key: 12280536
• MDR Text Key: 265356954
• Report Number: MW5103002
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 68 YR