BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOLLYPOP PACIFIER

    MDR report key: 13365871 · Received January 27, 2022

    Report

    Report Number
    13365871
    Event Type
    Malfunction
    Date Received
    January 27, 2022
    Date of Event
    January 24, 2022
    Report Date
    January 24, 2022
    Manufacturer
    SANDBOX MEDICAL LLC
    Product Code
    LQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NEW ADMISSION TO THE NICU. NEW JOLLYPOP PACIFIER OPEN FOR BABE UPON ADMISSION. SMALL PIECE OF PLASTIC OFF PACIFIER NOTICED INSIDE THE BABY'S MOUTH BY BABY'S CAREGIVER. PLASTIC PIECE ~ 2CM IN LENGTH. UPON EXAMINATION OF THE EDGE OF THE PACIFIER THERE IS NOT A SMOOTH EDGE, NOT ROUGH TO HURT TO THE BABY, BUT UNCLEAN "CUT" OF THE PLASTIC. THE PIECE OF FLIMSY AND THIN PLASTIC WAS REMOVED FROM THE INFANT'S MOUTH WITHOUT INCIDENCE. MANUFACTURER RESPONSE FOR PACIFIER, (BRAND NOT PROVIDED) (PER SITE REPORTER). THE MANUFACTURER HAS REQUESTED MORE INFORMATION IN ADDITION TO WANTING THE ITEM RETURNED. OFFER TO REPLACE BOX OF PACIFIERS AND HAS ISSUED A PATIENT COMPLAINT ON THEIR END. THE FIRST QUESTION ASKED WAS IF THE INFANT WAS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85443 JOLLYPOP PACIFIER DEVICE, FINGER-SUCKING LQX SANDBOX MEDICAL LLC 211234901

    Patients

    Seq Age Sex Outcome Treatment
    1 Female