FDA Adverse Event
Malfunction
Summary report: N
NANO CIC RECHARGEABLE HEARING AID
MDR report key: 17922578
·
Received October 11, 2023
Report
- Report Number
- MW5146839
- Event Type
- Malfunction
- Date Received
- October 11, 2023
- Date of Event
- September 26, 2023
- Report Date
- October 10, 2023
- Manufacturer
- NANO HEARING TECH OPCO, LLC
- Product Code
- QUF
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
REPORTER CALLING STATING "MY HEARING AIDS ARE NOT WORKING." REPORTER STATES HE PURCHASED THE NANO CIC RECHARGEABLE HEARING AIDS ONLINE HOWEVER AFTER RECEIVING THEM THEY ARE FAILING TO WORK FOR HIM. REPORTER STATES THERE IS NO CHANGE WHEN HE PRESSES THE VOLUME BUTTON ON HIS HEARING AIDS AND THEY HAVE NOT HELPED HIS HEARING. REFERENCE REPORT: MW5146838.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1312079 | NANO CIC RECHARGEABLE HEARING AID | HEARING AID, AIR-CONDUCTION, OVER THE COUNTER | QUF | NANO HEARING TECH OPCO, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Male |