MAUDE Adverse Event Report: EUFLEXXA; ACID, HYALURONIC INTRAARTICULAR

Device Problem Defective Device (2588)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/04/2018

Event Type  Injury  

Event Description

Was prescribed and injected euflexxa in both knees for oa.After three injections, the pain never improved.This product did not work.

• Brand Name: EUFLEXXA
• Type of Device: ACID, HYALURONIC INTRAARTICULAR
• MDR Report Key: 7689378
• MDR Text Key: 114206591
• Report Number: MW5078419
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR