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 |