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

Lot Number N10841A

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 06/15/2018

Event Type  Death  

Event Description

Pt's daughter reported that the pt has passed away.Bilateral primary osteoarthritis of knee.Therapy start date: (b)(6) 2017; therapy end date: (b)(6) 2018.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS, INC.
• MDR Report Key: 7772102
• MDR Text Key: 116882000
• Report Number: MW5079022
• 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
• Type of Report: Initial
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/12/2018
• Device Lot Number: N10841A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 67 YR