MAUDE Adverse Event Report: EXERCORE LLC EUSTACHI

Model Number EUSTACHI

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Nausea (1970); Tinnitus (2103); Dizziness (2194)

Event Date 03/17/2016

Event Type  Injury  

Event Description

Research eustachian tube on internet and a product called eustachi (open ears) came up with research.Ordered from (b)(6) for opening eustachian tubes in which i was recovering from acoustic trauma on (b)(6) 2015 with a malfunction volume of gym exerciser.I read the instructions and i did not have any precautions listed.To use the system, no time frame for using the equipment after initial use was given.I tried using the device 3 times within a two minute period.My ear started this high pitch ringing noise in which i still have (b)(6) 2016.Since this problem occurred using eustachi, i have been to a otologist, dr.(b)(6).In addition to the tinnitus, i have developed migraine headaches, eye sensitivity, nausea and dizziness.These are all signs of vestibular disorders.Too much air was put in the ear by (b)(6), (b)(6) 2016 and he prescribed alprazolam.25 mg to help with stress issues.I am still having the problems created with the eustachi.The two main problems with instructions were the precautions were not complete, i.E., ear trauma and the frequency of use.I have since learned that the ear popper is a similar product made by summitt medical and they require a prescription from a physician.Eustachi markets their product as a "eustachian tube exerciser" and does not require a prescription from a physician.This product is sold by (b)(6).I feel this product should be under control of a physician to prevent injuries from happening like mine.

• Brand Name: EUSTACHI
• Type of Device: EUSTACHI
• Manufacturer (Section D): EXERCORE LLC
• MDR Report Key: 5633711
• MDR Text Key: 45261153
• Report Number: MW5062090
• Device Sequence Number: 0
• Product Code: MJV
• 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: 05/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EUSTACHI
• Device Catalogue Number: EUSTACHIAN TUBE EXERCISER
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 79