BEUDAMED
    FDA Adverse Event Death Summary report: N

    THE TUCKER SLING

    MDR report key: 349965 · Received September 6, 2001

    Report

    Report Number
    MW1022758
    Event Type
    Death
    Date Received
    September 6, 2001
    Date of Event
    September 21, 2000
    Report Date
    August 31, 2001
    Manufacturer
    TUCKER DESIGNS, LTD
    Product Code
    FRP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEATH OCCURRED WHILE INFANT WAS SLEEPING IN PRONE POSITION USING THE TUCKER SLING, AN INFANT POSITIONING/HOLDER DEVICE, WHICH WAS BEING USED WITH A WEDGE IN A STANDARD SIZED CRIB. INFANT WAS POSITIONED IN ACCORDANCE WITH INSTRUCTIONS ACCOMPANYING THE TUCKER SLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40382 THE TUCKER SLING HOLDER/INFANT POSITIONING DEVICE FRP TUCKER DESIGNS, LTD UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 34 DAY Death