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

Device Problem Off-Label Use (1494)

Patient Problem No Information (3190)

Event Date 05/30/2019

Event Type  Injury  

Event Description

A rep from the dr's office called in to prescribe euflexxa to be injected into the shoulder and confirmed off label use.

• Brand Name: EUFLEXXA 1% SOLUTION FOR INJECTION 10MG/1ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD. C/O FERRING PHARMACEUTICALS INC.
• MDR Report Key: 8674747
• MDR Text Key: 147353708
• Report Number: MW5087150
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 05/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR