MAUDE Adverse Event Report: EUFLEXXA

Device Problem Insufficient Information (3190)

Patient Problems Chest Pain (1776); Headache (1880); High Blood Pressure/ Hypertension (1908)

Event Date 11/16/2015

Event Type  Injury  

Event Description

Euflexxa knee injection (b)(6) 2015, almost fainted, severe headache, bp increased, chest pain.Second euflexxa knee injection (b)(6) 2015, severe headache, bp increased, had to go to er.Continuing severe headache and blood pressure increase, i'm now on bp meds from my family doctor.Never had bp problems prior to injections.Severe headache from euflexxa caused bp increase.I'd like to know how long euflexxa will stay in my system causing me problems.Reason for use: left knee pain, meniscus tear.Event abated after use: no.

• Brand Name: EUFLEXXA
• Type of Device: EUFLEXXA
• MDR Report Key: 5381024
• MDR Text Key: 36497235
• Report Number: MW5059428
• Device Sequence Number: 1
• Product Code: MOZ
• 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: 01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 63 YR
• Patient Weight: 68