FDA Adverse Event Injury Summary report: N

NEBROO PRO 2.

MDR report key: 23495391 · Received November 6, 2025

Report

Report Number
MW5178573
Event Type
Injury
Date Received
November 6, 2025
Date of Event
October 22, 2025
Report Date
November 3, 2025
Manufacturer
AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD
Product Code
QUF
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MA, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

WE RECEIVED NEBROO HEARING AIDS IN THE MAIL BEFORE OUR TRIP TO OUR SON'S IN (B)(6). MY HUSBAND TRIED THE HEARING AIDS IN (B)(6) AND FOUND THE BEEPING NOISE UNBEARABLE NO MATTER HOW HE ADJUSTED THEM. WE RETURNED HOME TO (B)(6) ON (B)(6) 2025 AND HE WANTS TO RETURN THE AIDS. PATIENT CODE: 4582. DEVICE CODE: 3273. REFERENCE REPORT#: MW5178574.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1808154 NEBROO PRO 2. HEARING AID, AIR-CONDUCTION, OVER THE COUNTER QUF AUSTAR HEARING SCIENCE & TECHNOLOGY (XIAMEN) CO., LTD F703A

Patients

Seq Age Sex Outcome Treatment
1 79 YR Male