BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OHMEDA MEDICAL CARE PLUS

    MDR report key: 488285 · Received October 9, 2003

    Report

    Report Number
    1121732-2003-00007
    Event Type
    Injury
    Date Received
    October 9, 2003
    Date of Event
    August 31, 2003
    Report Date
    October 8, 2003
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT ISOLETTE AND DRAPED FOR PROCEDURE. ISOLETTE LEFT OPEN FOR 40 MINUTES. WHEN DRAPES REMOVES, REDDENED SKIN NOTED ON RIGHT SIDE OF BODY FROM FOOT TO AXILLA. BLISTERS NOTED ON RIGHT FOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OHMEDA MEDICAL CARE PLUS ISOLETTE FMZ OHMEDA MEDICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY Hospitalization