BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JABRA ENHANCE 200 HEARING AID

    MDR report key: 18537477 · Received January 17, 2024

    Report

    Report Number
    MW5150512
    Event Type
    Injury
    Date Received
    January 17, 2024
    Date of Event
    January 14, 2024
    Report Date
    January 15, 2024
    Manufacturer
    GN CONSUMER HEARING CORPORATION
    Product Code
    QUG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    HEARING AID RECEIVER BROKE IN TWO AND RECEIVER AND EAR BUD WERE DEEP IN CANAL AND NEEDED TO BE REMOVED IN A PROCEDURE. AFTERWARDS THERE WAS IRRITATION AND SCRATCHES IN THE EAR CANAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511543 JABRA ENHANCE 200 HEARING AID HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY, OVER THE COUNTER QUG GN CONSUMER HEARING CORPORATION 200

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention