BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE 2 PRO

    MDR report key: 22340610 · Received June 25, 2025

    Report

    Report Number
    MW5171997
    Event Type
    Injury
    Date Received
    June 25, 2025
    Date of Event
    June 15, 2025
    Report Date
    June 18, 2025
    Manufacturer
    UNKNOWN
    Product Code
    QUG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE DOME OF THE HEARING AID CAME OFF IN THE PERSONS INNER EAR AND NEEDED TO BE EXTRACTED. IN ADDITION, THE COMPANY THAT SELLS THE DEVICE OFFERS A 14-DAY "TRIAL" THE ADVERTISING OF THE TRIAL IS MISLEADING AS THE TRIAL STARTS ON THE DAY THE DEVICE IS SHIPPED NOT ON THE DAY THE DEVICE ARRIVES AT THE PATIENT HOME. WHEN THE PATIENT TRIED TO RETURN THE DEVICE IT WAS ONLY AFTER 12 DAYS BUT THEY STILL REFUSED TO SEND A RETURN LABEL AND CHARGED THE FULL AMOUNT FOR THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837669 PULSE 2 PRO HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY, OVER THE COUNTER QUG UNKNOWN G22 BEIGE(U)

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention B-12 DAILY.| MULTI VITAMIN.