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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Urticaria (2278)

Event Date 02/27/2020

Event Type  Injury  

Event Description

Patient called in stating that she has been having hives for an extended time 1 to 1.5 years, she has been using euflexxa with positive results and they are trying to rule out potential causes for patient¿s hives.She reports she has an egg and soy allergy.

• Brand Name: EUFLEXXA 1% SOLUTION FOR INJECTION 10MG/1ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS, INC.
• MDR Report Key: 9775243
• MDR Text Key: 181829318
• Report Number: MW5093431
• Device Sequence Number: 1
• Product Code: MOZ
• 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
• Type of Report: Initial
• Report Date: 02/27/2020

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: 02/28/2020
• Patient Sequence Number: 1
• Patient Age: 63 YR