BEUDAMED
    FDA Adverse Event Death Summary report: N

    HALO SLEEPSACK SWADDLE

    MDR report key: 1666076 · Received April 21, 2010

    Report

    Report Number
    1666076
    Event Type
    Death
    Date Received
    April 21, 2010
    Date of Event
    February 6, 2010
    Report Date
    April 20, 2010
    Manufacturer
    HALO INNOVATIONS
    Product Code
    FMQ
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B) (6) 2009, A MALE INFANT WAS DELIVERED AT (B) (4) AND THE MOTHER WAS PROVIDED WITH A HALO SLEEPSACK SWADDLE WHEN SHE WAS DISCHARGED FROM THE HOSPITAL. ON (B) (6) 2010, THE INFANT HAD THE SLEEPSACK SWADDLE ON AND APPARENTLY ROLLED OVER ON HIS BELLY. THE INFANT'S FACE WAS SMASHED INTO THE SIDE OF THE CRIB, ONE OF HIS ARMS WAS SWADDLED DOWN AND THE OTHER ARM WAS SWADDLED UPWARD. THE INFANT APPARENTLY SUFFOCATED WHEN HE ROLLED OVER BECAUSE HE COULD NOT USE HIS ARMS TO LIFT HIS HEAD UP. RISK MANAGEMENT RECEIVED NOTIFICATION OF THIS EVENT ON APRIL 15, 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALO SLEEPSACK SWADDLE SLEEPSACK SWADDLE FMQ HALO INNOVATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Death