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

Device Problem Off-Label Use (1494)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/03/2019

Event Type  Injury  

Event Description

Per (b)(4) authorization rep at mdo, prescriber (b)(6) is aware labeled use is for injection into the knee, wishes to proceed with injection in the hip.

• Brand Name: EUFLEXXA 1% SOLUTION FOR INJ 10MG/1ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FERRING PHARMACEUTICALS INC. / BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.
• MDR Report Key: 9172465
• MDR Text Key: 161812367
• Report Number: MW5090291
• 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: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• 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