VNG HEARING TEST

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-04 for VNG HEARING TEST manufactured by Unk.

Event Text Entries

[107633551] A caller called to report having a hearing test and when the admin of the test placed the nozzle of the device into his ear, he heard a loud sound that gave him discomfort, pain, and pressure. He states that it was so painful that he pushed the hand away of the admin. The reporter states that the admin had an option of using a 2-way nozzle and she didn't. He believes that it shouldn't have been an option for her to use a 1-way nozzle and that the 2-way nozzle is the better component for this procedure. He states that this should have been mandated by the mfr of this type of test so that people will not in chronic pain, and the feeling of pressure like has felt in his ears for ten months now. Reporter states that he has found three other people on the internet that had the same thing happen to them and that he plans to reach out to them so, they can too file a complaint with the fda.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW5077024
MDR Report Key	7490115
Date Received	2018-05-04
Date of Report	2018-05-04
Date of Event	2017-07-20
Date Added to Maude	2018-05-07
Event Key	0
Report Source Code	Voluntary report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	3
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 Details

Brand Name	VNG HEARING TEST
Generic Name	NYSTAGMOGRAPHY SYSTEM (VNG)
Product Code	GWN
Date Received	2018-05-04
Device Availability	*
Device Eval'ed by Mfgr	I
Device Sequence No	1
Device Event Key	0
Manufacturer	UNK
Manufacturer Address	UNK UNK

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2018-05-04