BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DECHOKER

    MDR report key: 11586110 · Received March 29, 2021

    Report

    Report Number
    3011422544-2021-00001
    Event Type
    Injury
    Date Received
    March 29, 2021
    Date of Event
    October 2, 2019
    Report Date
    October 22, 2019
    Product Code
    BSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEAR (B)(6), I DON'T THINK IT IS LIKELY THAT DECHOKER WOULD CAUSE ANY NEUROGENIC PULMONARY EDEMA. FORCED INSPIRATION AGAINST A CLOSED GLOTTIS CAN PRODUCE VERY NEGATIVE LOWER AIRWAY PULMONARY PRESSURES, AND THIS CAN CAUSE NPE. STRAINING WHILE CHOKING COULD CAUSE THIS. THE DECHOKER WILL BE CAUSING NEGATIVE PRESSURES IN THE OROPHARYNX, AND SHOULD NOT CAUSE ANY CHANGE IN THE LOWER AIRWAY PRESSURE BECAUSE THE OBSTRUCTING OBJECT IS BLOCKING IT. IT WOULD SEEM THAT AS SOON AS THE OBSTRUCTION IS RELEASED THAT THE AIRWAY PRESSURES WOULD NORMALIZE AND THE CHOKING PERSON WOULD TAKE A BIG INSPIRATORY BREATH. AS SOON AS THE FOREIGN BODY AIRWAY OBSTRUCTION IS REMOVED THE DECHOKER WOULD BE REMOVED FROM THE FACE AND NO FURTHER NEGATIVE PRESSURES WOULD OCCUR.

    Description of Event or Problem · 1

    ON WEDNESDAY, (B)(6) 2019 AT 10:29AM DR. (B)(6) OF DECHOKER (B)(4) INFORMED DECHOKER CEO THAT AEMPS HAD BEEN FORMALLY NOTIFIED THAT AN EVENT HAD OCCURED ON (B)(6) 2019. THE PRELIMINARY REPORT STATES THE FOLLOWING: USE OF [UNKNOWN MODEL, SIZE] DECHOKER DEVICE BY NON SANITARY SCHOOL PERSONNEL TO REMOVE OBJECT IN A CASE OF COMPLETE AIRWAY OBSTRUCTION IN A 3 YEAR OLD CHOKING VICTIM. OVACE SAVING MANEUVERS WERE ALSO USED, INCLUDING THE HEIMLICH MANEUVER. ACCORDING TO DR. (B)(6), THE EMERGENCY PHYSICIAN ON THE AMBULANCE, THE DEVICE WAS VERY RIGID AND IT REACHED THE OROPHARYNX CAUSING INJURY. IT WAS LATER DETERMINED THAT THE CHILD WAS CHOKING ON A GRAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482657 DECHOKER DECHOKER FOR CHILDREN BSY 01DCH03

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Hospitalization