BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTANT HOT PACK MCKESSON GENERAL PURPOSE LARGE

    MDR report key: 13499912 · Received February 8, 2022

    Report

    Report Number
    MW5107317
    Event Type
    Injury
    Date Received
    February 8, 2022
    Date of Event
    January 22, 2022
    Report Date
    February 4, 2022
    Manufacturer
    MCKESSON MEDICAL SURGICAL INC.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NEWBORN INFANT HYPOTHERMIC AT BIRTH. ADMITTED TO NICU. HEAT PACK PLACED ON RIGHT FOOT TO DILATE VEIN FOR IV START. PRODUCT PLACED DIRECTLY TO FOOT. BETWEEN 1-2 MINUTES OF TIME, BLISTERS OCCURRED ON THE RIGHT FOOT ON (3) SURFACES: FOOT, ANKLE AND HEEL SURROUNDED BY ERYTHEMA. MD AND WOUND TEAM NOTIFIED. PATIENT IS BEING FOLLOWED BY PLASTICS. BURNS TO RIGHT FOOT ARE SUPERFICIAL AND DEEP THICKNESS. TOTAL BODY SURFACE AREA (TBSA) 1%. BURN WOUNDS DEMONSTRATING SIGNS OF HEALING ON CURRENT WOUND REGIMEN. FDA SAFETY REPORT ID (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757343 INSTANT HOT PACK MCKESSON GENERAL PURPOSE LARGE PACK, HOT OR COLD, DISPOSABLE IMD MCKESSON MEDICAL SURGICAL INC. 16-9707 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Male Other