MAUDE Adverse Event Report: FERRING PHARMACEUTICALS, INC./ BIO-TECHNOLOGY GENERAL (ISREAL) LTD. EUFLEXXA 1% SOLUTION FOR INJ. 10MG/1ML; ACID, HYALURONIC, INTRAARTICULAR

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

Patient Problem Anemia (1706)

Event Date 12/20/2019

Event Type  Injury  

Event Description

The patient was in the hospital due to being anemic.Stated they added an antacid for 30 days but didn¿t know the name of it.No missed dose.

• Brand Name: EUFLEXXA 1% SOLUTION FOR INJ. 10MG/1ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS, INC./ BIO-TECHNOLOGY GENERAL (ISREAL) LTD.
• MDR Report Key: 9538823
• MDR Text Key: 173507708
• Report Number: MW5091958
• 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: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR