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

Lot Number R13444A

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 08/02/2020

Event Type  Injury  

Event Description

Patient passed away on (b)(6) 2020.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS INC.
• MDR Report Key: 10534762
• MDR Text Key: 207135757
• Report Number: MW5096594
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 55566410001
• UDI-Public: 55566410001
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/07/2021
• Device Lot Number: R13444A
• Patient Sequence Number: 1
• Patient Age: 95 YR