BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORICLE HEARING AID 2.0

    MDR report key: 22338091 · Received June 25, 2025

    Report

    Report Number
    MW5171941
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    June 19, 2025
    Report Date
    June 19, 2025
    Manufacturer
    LIFETIME WELL LLC.
    Product Code
    QUH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE -PUBLICITY ORICLE HEARING AID IS TOTALLY A WRONG PRODUCT OF THIS DISTRIBUTOR LIFETIME WELL LLC. 2400 KETTNER BLVD # 212, SAN DIEGO, CA 92101; PHONE# 1-833-258-8167 AND E-MAIL: [email protected]. "MANUFACTURED UNDER STRICT QUALITY STANDARDS, THE DEVICE COMPLIES WITH IEC60601-1, IEC601 18-7/13, ISO 10993 ISO1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940172 ORICLE HEARING AID 2.0 SELF-FITTING AIR-CONDUCTION HEARING AID, OVER THE COUNTER QUH LIFETIME WELL LLC. JH-A490 24PI401

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown