MAUDE Adverse Event Report: EUFLEXXA; ACID HYALURONIC

Device Problem Material Integrity Problem (2978)

Patient Problem Pain (1994)

Event Date 07/03/2018

Event Type  Injury  

Event Description

Pt feels like the euflexxa isn't working and she's still experiencing pain.Rated pain level at a 10.She had 3 injections and her last injection was on (b)(6) 2018.Advised her to contact her dr to discuss alternatives.Advised her to take no more than 3000mg of acetaminophen per day to see if that helps.Dates of use: 1 month."is the product compounded: no; is the product over-the-counter: no." inj 10mg/ml.

• Brand Name: EUFLEXXA
• Type of Device: ACID HYALURONIC
• MDR Report Key: 7677330
• MDR Text Key: 113778871
• Report Number: MW5078314
• 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: 07/03/2018
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2018
• 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: 60 YR