BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO-SHAPED LIL BLINK

    MDR report key: 25711 · Received September 18, 1995

    Report

    Report Number
    MW1006935
    Event Type
    Malfunction
    Date Received
    September 18, 1995
    Date of Event
    September 6, 1995
    Report Date
    September 6, 1995
    Manufacturer
    BLINKY GRIPTIGHT, INC.
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHITE END OF PACIFIER CAME OUT OF THE MOUTHPIECE & COULD BE A CHOKING HAZARD TO THE NEWBORN. CHECKING REMAINDER OF PACIFIERS IN THE CASE ON THE OB UNIT REVEALED 14 MORE WITH THE SAME WHITE PLASTIC PLUG WHICH COULD BE PULLED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO-SHAPED LIL BLINK NEWBORN ORTHODONTIC PACIFIER BLINKY GRIPTIGHT, INC. 3083 L548

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other