BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOLLYPOP PACIFIER

    MDR report key: 4664611 · Received March 31, 2015

    Report

    Report Number
    MW5041876
    Event Type
    Malfunction
    Date Received
    March 31, 2015
    Date of Event
    March 27, 2015
    Report Date
    March 31, 2015
    Manufacturer
    SANDBOX MEDICAL LLC
    Product Code
    LQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    HOSPITAL STAFF WERE CONTACTED BY MOTHER OF INFANT BORN IN (B)(6) 2014. SHE CLAIMS HER INFANT SUCKED THE END OFF OF A JOLLYPOP PACIFIER THAT WAS GIVEN TO HER WHILE SHE WAS A PT HERE. SUPPOSEDLY THE MOTHER NEEDED TO RETRIEVE THE END PIECE FROM THE BABY'S MOUTH BEFORE IT WAS SWALLOWED. SHE CLAIMS THIS WAS THE SECOND TIME A TIP CAME OFF OF A PACIFIER MANUFACTURED BY THIS COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213354 JOLLYPOP PACIFIER BABY PACIFIER LQX SANDBOX MEDICAL LLC JP 1303

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR