BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOGUARD THERMAL REFLECTOR

    MDR report key: 229999 · Received June 29, 1999

    Report

    Report Number
    229999
    Event Type
    Malfunction
    Date Received
    June 29, 1999
    Date of Event
    June 22, 1999
    Report Date
    June 28, 1999
    Manufacturer
    CAS MEDICAL SYSTEMS, INC.
    Product Code
    FLL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SKIN TEMPERATURE PROBE ATTACHED TO ABDOMEN WITH PROBE COVER. WHEN PROBE COVER WAS REMOVED, SKIN WAS REMOVED WITH IT, LEAVING A LARGE AREA OF OPEN TISSUE EXPOSED. AS INFANT AGED, NEW AREAS OF BLISTERING APPEARED, UNRELATED TO SKIN PROBE AREA (GROIN, HAND, FOOT). INFANT TO BE TRANSFERRED TO TERTIARY CENTER FOR POSSIBLE SKIN CONDITION-UNRELATED TO SKIN PROBE COVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOGUARD THERMAL REFLECTOR SKIN PROBE COVER FLL CAS MEDICAL SYSTEMS, INC. NA NA
    2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Other