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

Lot Number P14216A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 11/13/2019

Event Type  Injury  

Event Description

(b)(6) had a right knee replacement 2 days ago.

• Brand Name: EULFEXXA
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS INC.
• MDR Report Key: 9354197
• MDR Text Key: 167597464
• Report Number: MW5091222
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/28/2020
• Device Lot Number: P14216A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 58 YR