MAUDE Adverse Event Report: FERRING PHARMACEUTICALS EUFLEXXA INJ 10MG/ML; ACID, HYALURONIC INTRAARTICULAR

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Missed Dose (2561)

Event Date 12/13/2018

Event Type  Injury  

Event Description

The euflexxa order is lost in the mail.It did not make it to the doctor's office.As a result, the patient missed their scheduled injection.A replacement is being sent.The pt has spoken with the doctor.They will reschedule.Dates of use: (b)(6) 2018 - present.

• Brand Name: EUFLEXXA INJ 10MG/ML
• Type of Device: ACID, HYALURONIC INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS
• MDR Report Key: 8194353
• MDR Text Key: 131545875
• Report Number: MW5082526
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 12/13/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR