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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 02/04/2020

Event Type  Injury  

Event Description

Pt reports having knee injections before and doing fine, but the injection she received a week ago in office, she reports has made her sick for a full week.She reports no redness / swelling at the injection site but that she is sick to her stomach for a full week after receiving the injection.Rph.

• Brand Name: EUFLEXXA 1% SOLUTION FOR INJECTION 10MG/1ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS INC.
• MDR Report Key: 9694962
• MDR Text Key: 178780015
• Report Number: MW5092922
• 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: 02/04/2020

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/10/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR