BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OTC, HEARING AID, IN EAR, BLACK,SET OF 2

    MDR report key: 23583896 · Received November 18, 2025

    Report

    Report Number
    1417592-2025-00641
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    October 13, 2025
    Report Date
    November 18, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    QUF
    UDI-DI
    00197344013244
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, HIS HEARING AIDS KEPT FALLING OUT. PER THE CUSTOMER, "THE RUBBER PIECE ON THE END THAT FITS IN HIS EAR WAS HOLLOW AND GOT STUCK AND HE HAD TO GO TO THE DOCTOR TO GET IT REMOVED." NO ADDITIONAL INFORMATION AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER, HIS HEARING AIDS KEPT FALLING OUT. PER THE CUSTOMER, "THE RUBBER PIECE ON THE END THAT FITS IN HIS EAR WAS HOLLOW AND GOT STUCK AND HE HAD TO GO TO THE DOCTOR TO GET IT REMOVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1989267 OTC, HEARING AID, IN EAR, BLACK,SET OF 2 QUF MEDLINE INDUSTRIES, LP 3382405210 00197344013244

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other