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

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Missed Dose (2561)

Event Date 01/20/2020

Event Type  No Answer Provided  

Event Description

Pt missed scheduled dose, due to shipping error.

• Brand Name: EUFLEXXA 1% SOLUTION FOR INJECTION 10MG/1ML
• Type of Device: ACID, HYALURONIC, INTRA ARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS INC.
• MDR Report Key: 9627270
• MDR Text Key: 176406156
• Report Number: MW5092478
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/23/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR