BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPRESSOR,NEBULIZER, CHARACTER, PUP

    MDR report key: 20892956 · Received December 10, 2024

    Report

    Report Number
    1417592-2024-01013
    Event Type
    Injury
    Date Received
    December 10, 2024
    Date of Event
    November 11, 2024
    Report Date
    December 24, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    BTI
    UDI-DI
    00888277678166
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE TO H6: INVESTIGATION FINDINGS. UPDATE TO H6: INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, "A FEW WEEKS AGO" THE NEBULIZER STARTED TURNING ON BUT NOT DISPENSING THE "ALBUTEROL" MEDICATION TO HER SON. THE CUSTOMER REPORTED HER SON TAKES ALBUTEROL FOR HIS "ASTHMA" BUT, SINCE THE NEBULIZER STOPPED WORKING, HE HAS DEVELOPED "SHORTNESS OF BREATH, COUGHING, AND BRONCHITIS". THE CUSTOMER REPORTED AFTER THE NEBULIZER STOPPED WORKING, SHE VISITED HIS PHYSICIAN AND WAS GIVEN AN "ALBUTEROL" INHALER, HOWEVER HER SON IS UNABLE TO FOLLOW THE DIRECTIONS IN ORDER TO APPROPRIATELY TAKE THE INHALER DUE TO HIS AGE. THE CUSTOMER REPORTED SHE WENT TO THE EMERGENCY ROOM ON (B)(6) 2024 DUE TO SHORTNESS OF BREATH AND COUGHING, AND HER SON WAS GIVEN A "STEROID". THE CUSTOMER REPORTED THE EMERGENCY ROOM ALSO PERFORMED AN "XRAY" WHICH SHOWED "SOMETHING ON HIS LUNG". THE CUSTOMER REPORTED SINCE THE EMERGENCY ROOM VISIT, HIS SHORTNESS OF BREATH AND COUGHING HAS GOTTEN "A LITTLE BETTER". NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER, "A FEW WEEKS AGO" THE NEBULIZER STARTED TURNING ON BUT NOT DISPENSING THE "ALBUTEROL" MEDICATION TO HER SON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2534166 COMPRESSOR,NEBULIZER, CHARACTER, PUP BTI MEDLINE INDUSTRIES, LP 6462212 00888277678166

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Male Other