MAUDE Adverse Event Report: FERRING PHARMACEUTICALS INC. EUFLEXXA 1% SOLUTION FOR INJECTION 10MG/1ML ; ACID, HYALURONIC, INTRAARTICULAR

Lot Number P10006A

Device Problem Expiration Date Error (2528)

Patient Problem No Patient Involvement (2645)

Event Date 10/30/2019

Event Type  Injury  

Event Description

Spoke with (b)(6), medical assistant who stated 1 syringe out of the 3 expired before the pt can use.

• Brand Name: EUFLEXXA 1% SOLUTION FOR INJECTION 10MG/1ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS INC.
• MDR Report Key: 9342681
• MDR Text Key: 167192589
• Report Number: MW5091166
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 55566410001
• UDI-Public: 55566410001
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: P10006A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/18/2019
• Patient Sequence Number: 1
• Patient Age: 68 YR