FDA Adverse Event
Injury
Summary report: N
NANO CIC DIGITAL RECHARGE HEARING AIDS
MDR report key: 17836621
·
Received September 27, 2023
Report
- Report Number
- MW5146267
- Event Type
- Injury
- Date Received
- September 27, 2023
- Date of Event
- September 25, 2023
- Report Date
- September 25, 2023
- Manufacturer
- NANO HEARING TECH OPCO, LLC
- Product Code
- QUG
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
USED NANO CIC HEARING AIDS FOR FIRST TIME. TOOK OUT LEFT DEVICE AND THE RUBBER PORTION OF AID WAS LODGED IN MY EAR CANAL. I WENT TO AN URGENT CARE TO HAVE IT REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1003573 | NANO CIC DIGITAL RECHARGE HEARING AIDS | HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY, OVER THE COUNTER | QUG | NANO HEARING TECH OPCO, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Female | Required Intervention | HEARING AIDES.| PRILOSEC.| ZOLOFT. |