MAUDE Adverse Event Report: NOT KNOWN; NONE

Device Problem Nonstandard Device (1420)

Patient Problems Hearing Impairment (1881); Increased Sensitivity (2065); Discomfort (2330)

Event Date 12/19/2011

Event Type  Injury  

Event Description

On (b)(6) 2011, dr.(b)(6) performed a eustachian tube dilation procedure on both ears.I had continued to experience eustachian tube dysfunction symptoms (discomfort in my ear) following a successful deviated septum repair in (b)(6) 2011.Dr.(b)(6) suggested an experimental procedure using an unapproved device.I agreed to the procedure, but noticed adverse effects immediately following the surgery which continues to this day.My ears felt blocked and my voice echoed when i spoke.Dr.(b)(6) said it should ease off, but a few months later i was still experiencing issues.When my allergies flare up and when i am sick my ears are very sensitive.I can feel the blood flow to my ears.I have seen 2 ents who have both diagnosed me as having patulous eustachian tubes - one in 2012 and once again in (b)(6) 2015.

• Brand Name: NOT KNOWN
• Type of Device: NONE
• MDR Report Key: 4412512
• MDR Text Key: 5415819
• Report Number: MW5040164
• Device Sequence Number: 1
• Product Code: LRC
• 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: 01/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 44 YR
• Patient Weight: 70