BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EUSTACHIAN TUBE BALLOON DILATION DEVICE

    MDR report key: 19309972 · Received May 13, 2024

    Report

    Report Number
    MW5154791
    Event Type
    Injury
    Date Received
    May 13, 2024
    Date of Event
    May 7, 2024
    Report Date
    May 9, 2024
    Manufacturer
    UNKNOWN
    Product Code
    PNZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    CHILD CLAIMED EAR DISCOMFORT AND INTERMITTENT PAIN. PEDIATRICIAN IN AN EARLIER VISIT CLAIMS A NERVE THAT COULD CAUSE THE FEELING AS EXPRESSED BY THE CHILD. HAS TWO FOREIGN OBJECTS TO DRAIN EARS. TUBES ARE IN BOTH SINUS AREAS OR REGIONS OF THE HEAD. COULD BE THESE TUBES CAUSING NERVE ACTIVATION? TUBES TO DRAIN EARS ON A CHILD. MEDICAL IMPLANTS. MANUFACTURER: UNSURE. REFERENCE REPORT: MW5154792.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1546743 EUSTACHIAN TUBE BALLOON DILATION DEVICE EUSTACHIAN TUBE BALLOON DILATION DEVICE PNZ UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Male Disability ALBUTEROL.| CETIRIZINE.| FLOVENT.| FLUTICASONE.