BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T.G. PERINATAL PRODUCTS

    MDR report key: 11773 · Received January 25, 1994

    Report

    Report Number
    11773
    Event Type
    Injury
    Date Received
    January 25, 1994
    Date of Event
    December 2, 1993
    Report Date
    December 7, 1993
    Manufacturer
    TRANSIDYNE GENERAL CORP.
    Product Code
    FMT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AT 0325, INFANT, 33 WKS GESTATION, ADMITTED TO NURSERY WITH TEMPERATURE OF 96 DEGREES. PLACED UNDER RADIANT WARMER. OXYGEN HOOD IN PLACE INITIALLY 90-80% THEN DECREASED. INFANT DRAPED FOR INSERTION OF UMBILICAL ARTERY CATHETER. INFANT WAS PLACED DIRECTLY ON PAD. AT 0421 DRAPE SHEET PLACED BETWEEN BABY AND PAD. AT 0630 LARGE RED AREAS NOTED ON BACK AND UPPER CHEST, ALSO REDNESS ON RIGHT CHEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T.G. PERINATAL PRODUCTS DISPOSABLE INFANT CRIB WARMER FMT TRANSIDYNE GENERAL CORP. 90616 30106

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Hospitalization| R