EUSTACHI EUSTACHIAN TUBE EXERCISER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-02 for EUSTACHI EUSTACHIAN TUBE EXERCISER manufactured by Exercore Llc.

Event Text Entries

[45261153] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5062090
• MDR Report Key: 5633711
• Date Received: 2016-05-02
• Date of Report: 2016-05-02
• Date of Event: 2016-03-17
• Date Added to Maude: 2016-05-05
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 0

• Brand Name: EUSTACHI
• Generic Name: EUSTACHI
• Product Code: MJV
• Date Received: 2016-05-02
• Model Number: EUSTACHI
• Catalog Number: EUSTACHIAN TUBE EXERCISER
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: EXERCORE LLC

Device Sequence Number: 1

• Brand Name: EUSTACHI
• Generic Name: EUSTACHI
• Product Code: TBD
• Date Received: 2016-05-02
• Model Number: EUSTACHI
• Catalog Number: EUSTACHIAN TUBE EXERCISER
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: EXERCORE LLC

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2016-05-02