BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-MAN PACIFIER

    MDR report key: 58218 · Received December 19, 1996

    Report

    Report Number
    58218
    Event Type
    Injury
    Date Received
    December 19, 1996
    Date of Event
    November 7, 1996
    Report Date
    December 17, 1996
    Manufacturer
    SASSY, INC.
    Product Code
    LQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PACIFIER PLACED IN MOUTH OF CRYING NEWBORN FOUND IN PIECES WHEN NURSE RETURNED TO CRIB. CAME APART INTO 3 SMALL PIECES, ANY OF WHICH WERE SMALL ENOUGH TO PRESENT AN ASPIRATION HAZARD TO A NEWBORN. NO ACTUAL PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI-MAN PACIFIER PACIFIER LQX SASSY, INC. MINI-MAN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 HR Required Intervention