MAUDE Adverse Event Report: EUFLEXXA 10 MG MILLIGRAM(S); ACID, HYALURONIC, INTRAARTICULAR

Lot Number N14370A

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Type  Death  

Event Description

The pt's spouse mailed a letter and advised that the pt is now deceased.No add'l details provided.Date of event and date of death is unk.Dose or amount: 2 ml millilitre(s), frequency: weekly, route: intra-articular.Therapy start date: (b)(6) 2017.Diagnosis or reason for use: bilateral primary osteoarthritis of knee.

• Brand Name: EUFLEXXA 10 MG MILLIGRAM(S)
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• MDR Report Key: 7846332
• MDR Text Key: 119336041
• Report Number: MW5079553
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 55566410001
• UDI-Public: 55566410001
• 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: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 04/14/2019
• Device Lot Number: N14370A
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 76 YR