BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLAYHOUSE MD MEDICINE BUDDY MEDICINE DISPENSER - BUTTERFLY

    MDR report key: 23657927 · Received November 26, 2025

    Report

    Report Number
    3038282348-2025-00001
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    October 24, 2025
    Report Date
    October 24, 2025
    Manufacturer
    PLAYHOUSE METHOD INC. D/B/A PLAYHOUSE MD
    Product Code
    KYX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE CUSTOMER HAS DECLINED TO RETURN THE DEVICE OR PROVIDE ANY FURTHER INFORMATION OR MEDICAL RECORDS AT THIS TIME, DESPITE MULTIPLE REQUESTS, PLAYHOUSE MD HAS BEEN UNABLE TO ASSESS THE DEVICE, THE SEVERITY OF ANY CLAIMED INJURY, OR WHETHER TREATMENT IS ONGOING OR MAY BE REQUIRED IN THE FUTURE.

    Description of Event or Problem · 0

    ON (B)(6) 2025, A CUSTOMER ALERTED PLAYHOUSE MD TO A POTENTIAL ADVERSE EVENT THROUGH A PRODUCT REVIEW SUBMITTED TO THE WEBSITE, IN WHICH SHE INDICATED THAT HER 3 MONTH OLD CHILD REQUIRED TREATMENT IN THE EMERGENCY ROOM. PLAYHOUSE MD FOLLOWED UP AND INQUIRED TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PRODUCT, THE POSSIBLE EVENT, AND THE PATIENT. THE CUSTOMER RESPONDED BY IDENTIFYING THE PRODUCT AS THE "BUTTERFLY SYRINGE," STATED THAT IT HAD "CAUSED ASPHYXIATION" THAT "CAUSED ME TO HAVE TO DO CHEST COMPRESSIONS AND CALL 911," AND THAT "[T]HANKFULLY SHE IS OK NOW AFTER A FULL DAY IN EMERGENCY ROOM VIA AMBULANCE." ON OCTOBER 27, 2025, PLAYHOUSE MD FOLLOWED UP TO REQUEST INFORMATION NEEDED TO ASSESS THE EVENT, INCLUDING ABOUT HOW THE PRODUCT WAS BEING USED, WHAT OCCURRED DURING THE USE OF THE PRODUCT, IDENTIFICATION OF THE SPECIFIC PRODUCT BY SERIAL NUMBER, A REQUEST FOR PHOTOGRAPHS, AND WHERE AND HOW IT WAS PURCHASED. THE CUSTOMER RESPONDED SAYING, "I USED YOUR SYRINGE EXACTLY AS MARKETED, TO ADMINISTER GRIPE WATER TO MY INFANT. THE DEVICE'S INTERNAL PRESSURE MECHANISM CAUSED THE LIQUID TO SHOOT FORCEFULLY TO THE BACK OF HER THROAT, TRIGGERING ACUTE AIRWAY OBSTRUCTION, SEVERE FOAMING AT THE MOUTH, AND A PERIOD OF NON-RESPONSIVENESS. FOLLOWING INSTRUCTIONS FROM THE 911 DISPATCHER, I PERFORMED INFANT CHEST COMPRESSIONS UNTIL EMERGENCY RESPONDERS ARRIVED. MY DAUGHTER WAS TRANSPORTED BY AMBULANCE TO THE EMERGENCY DEPARTMENT, WHERE SHE WAS MONITORED FOR OXYGEN DESATURATION, UNDERWENT IMAGING, AND WAS OBSERVED FOR SEVERAL HOURS." THE CUSTOMER REPORTED THAT THE CHILD'S "OXYGEN LEVELS STABILIZED AND HER LUNGS APPEARED CLEAR" BUT THAT THE CHILD CONTINUED TO EXPERIENCE "AIRWAY TRAUMA AND PERSISTENT COUGHING MORE THAN 72 HOURS LATER (STILL PRESENT); LOSS OF NORMAL CRY AND THROAT PAIN: MY DAUGHTER REMAINS UNABLE TO CRY PROPERLY DUE TO PAIN AND IRRITATION IN HER THROAT. WHEN ATTEMPTING TO CRY, SHE STRAINS AND BEGINS COUGHING, WHICH CAUSES VISIBLE DISCOMFORT AND FURTHER DISTRESS TO HER [...]" ON OCTOBER 30, 2025, PLAYHOUSE MD SENT THE CUSTOMER A LETTER AGAIN REQUESTING ADDITIONAL INFORMATION NEEDED TO INVESTIGATE AND ASSESS THE EVENT FOR POSSIBLE REPORTING, INCLUDING INFORMATION ABOUT HOW SHE WAS USING THE PRODUCT AT THE TIME OF THE INCIDENT, AS WELL AS RETURN OF THE PRODUCT FOR EXAMINATION, AND DEMOGRAPHIC INFORMATION ABOUT THE CHILD'S SEX, DATE OF BIRTH, CURRENT WEIGHT, RACE/ETHNICITY, AND ANY PRE-EXISTING MEDICAL CONDITIONS. PLAYHOUSE MD ALSO REQUESTED RECORDS FROM ANY MEDICAL TREATMENT THE PATIENT RECEIVED. ON (B)(6) 2025, THE CUSTOMER RESPONDED AND REFUSED TO PROVIDE FURTHER INFORMATION, RECORDS, OR TO RETURN THE PRODUCT FOR INSPECTION. SHE DESCRIBED THE EVENT AS "CHOKING, ASPIRATION, AND BRIEF ASPHYXIATION -- LEADING TO MY HAVING TO PERFORM CPR TO SAVE MY CHILD." SHE ALSO STATED THE CHILD WAS THREE MONTHS AND ONE WEEK OLD AT THE TIME, OF NORMAL WEIGHT, HAD NO PRIOR MEDICAL OR FEEDING ISSUES, AND THE PRODUCT "WAS USED EXACTLY IN ACCORDANCE WITH YOUR INSTRUCTIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2030302 PLAYHOUSE MD MEDICINE BUDDY MEDICINE DISPENSER - BUTTERFLY DISPENSER, LIQUID MEDICATION KYX PLAYHOUSE METHOD INC. D/B/A PLAYHOUSE MD 1012 10725NT

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Female Other