BEUDAMED
    FDA Adverse Event Death Summary report: N

    SQUISHON 3

    MDR report key: 65590 · Received December 30, 1996

    Report

    Report Number
    65590
    Event Type
    Death
    Date Received
    December 30, 1996
    Date of Event
    November 20, 1996
    Report Date
    November 25, 1996
    Manufacturer
    CHILDREN'S MEDICAL VENTURES
    Product Code
    FMP
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INFANT FED AT 0330 - POSITIONED IN BASSINET ON SIDE. INFANT WAS FOUND FACE DOWN IN PILLOW 0545 WITHOUT PULSE/RESPIRATIONS, CYANOTIC. RESUSCITATED, INTUBATED ON VENTILATOR. EVENTUALLY LIFE SUPPORT REMOVED DUE TO GRIM PROGNOSIS. INFANT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SQUISHON 3 GEL PILLOW/POSITIONING AID FMP CHILDREN'S MEDICAL VENTURES 91033-3 *

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO Death