BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EAR TUBES

    MDR report key: 19560766 · Received June 17, 2024

    Report

    Report Number
    MW5156388
    Event Type
    Injury
    Date Received
    June 17, 2024
    Date of Event
    June 12, 2024
    Report Date
    June 13, 2024
    Manufacturer
    UNKNOWN
    Product Code
    QJA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE CLAIM FROM THE PATIENT IS THAT PAIN IN THE AREA OF THE EAR TUBE. THIS WAS CONFIRMED BY THE ATTEMPTED REMOVAL BY THE PEDIATRICIAN. THIS ISSUE HAS BEEN REPORTED BY THE PATIENT SINCE OR NEAR THE TIME OF IMPLANTING ON (B)(6) 2023 BY AN ENT (EAR, NOSE, AND THROAT). THIS HAS BEEN CHRONIC AND CONTINUES. THE PATIENT CLAIMED THE PAIN WAS EXACT BUT INCREASED BY THE ATTEMPTED REMOVAL OF THE TUBE AS IT WAS CLAIMED TO BE OUT AND HANGING. THE TUBES STILL EXIST IN THE PATIENT BUT THE PLAN OF ACTION FOR TREATMENT INCLUDE IBUPROFEN, FLUTICASONE, CETIRIZINE, SALINE SOLUTION TO THE EAR BEYOND THE OTHER MEDICINES TO THE NASAL. AND DRINK FOR ALLERGIES OR NASAL INFLAMMATION AND IRRITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1512866 EAR TUBES TYMPANOSTOMY TUBE DELIVERY PRODUCT WITH DRUG QJA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Male Disability ALBUTEROL.| CETIRIZINE.| FLUTICASONE QVAR. | SALINE SOLUTION.