BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDI FRIDA THE ACCU-DOSE PACIFIER BABY MEDICINE DISPENSER BY FRIDABABY

    MDR report key: 14014907 · Received April 4, 2022

    Report

    Report Number
    MW5108756
    Event Type
    Injury
    Date Received
    April 4, 2022
    Date of Event
    March 31, 2022
    Report Date
    March 31, 2022
    Manufacturer
    FRIDABABY LLC.
    Product Code
    KYX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MEDI FRIDA THE ACCU-DOSE PACIFIER BABY MEDICINE DISPENSER BY FRIDABABY - HUB OF SYRINGE ATTACHES TO OUTER PART OF PACIFIER, AND MEDICATION PASSES THROUGH A THIN TUBE TO EXIT AT TIP OF PACIFIER. PROBLEM IS, THE TUBE TRAPS 0.2 ML OF MEDICATION, WHICH DOES NOT DISPENSE, AS IT IS JUST STUCK IN THERE ONCE THE SYRINGE PLUNGER MEETS THE HUB. THIS DEVICE IS FOR BABIES, AND BABY DOSES OF MEDICATION ARE OFTEN VERY SMALL - SO YOU COULD LITERALLY BE GIVING HALF THE DOSE OR EVEN LESS (ONE PERSON ON AMAZON ASKED IF IT COULD MEASURE 0.3 ML AND THE COMPANY POSTED AN ANSWER STATING YOU COULD - BUT IN THIS CASE THE CHILD WOULD ONLY GET ONE THIRD OF HER DOSE, AS 0.2 ML WOULD REMAIN INSIDE THE DEVICE). DEVICE SHOULD BE PULLED FROM THE MARKET, OR ALTERNATIVELY, IT SHOULD BE CLEARLY LABELED THAT AN ADDITIONAL 0.2 ML MUST BE LOADED INTO THE SYRINGE IN ORDER TO DISPENSE THE CORRECT AMOUNT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440302 MEDI FRIDA THE ACCU-DOSE PACIFIER BABY MEDICINE DISPENSER BY FRIDABABY DISPENSER, LIQUID MEDICATION KYX FRIDABABY LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Male Disability FAMOTIDINE