MAUDE Adverse Event Report: EUFLEXXA INJ 10MG / ML ; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Insufficient Information (3190)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 07/29/2016

Event Type  Injury  

Event Description

Pt reports a lack of response to the euflexxa, rph.Dates of use: from (b)(6) 2016 to (b)(6) 2017.The product was not compounded; the product was not over-the-counter.

• Brand Name: EUFLEXXA INJ 10MG / ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• MDR Report Key: 7842469
• MDR Text Key: 119327293
• Report Number: MW5079549
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 55566410001
• UDI-Public: 55566410001
• Combination Product (y/n): N
• 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: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• 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: 66 YR