FDA Adverse Event
Malfunction
Summary report: N
OTC, HEARING AID, IN EAR, BLACK,SET OF 2
MDR report key: 25336884
·
Received May 29, 2026
Report
- Report Number
- 1417592-2026-01790
- Event Type
- Malfunction
- Date Received
- May 29, 2026
- Date of Event
- April 29, 2026
- Report Date
- May 29, 2026
- Manufacturer
- MEDLINE INDUSTRIES, LP
- Product Code
- QUF
- UDI-DI
- 00197344013244
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
IT WAS REPORTED THAT THE RIGHT EAR BUD IS NOT DETECTING/WORKING. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.
Description of Event or Problem · 0
AS PER THE REPORT, THE RIGHT EAR BUD IS NOT DETECTING/WORKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 496722 | OTC, HEARING AID, IN EAR, BLACK,SET OF 2 | QUF | MEDLINE INDUSTRIES, LP | BK12405119 | 00197344013244 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |