BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICHOICE INSTANT WARM PACK

    MDR report key: 6998861 · Received November 3, 2017

    Report

    Report Number
    6998861
    Event Type
    Injury
    Date Received
    November 3, 2017
    Date of Event
    August 15, 2017
    Report Date
    October 26, 2017
    Manufacturer
    OWENS & MINOR DISTRIBUTION, INC.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INSTANT WARM COMPRESS PLACED ON PATIENT'S SHOULDER AFTER SURGERY. COMPRESS REMOVED BY RN WHO NOTED REDDENED SKIN, WHICH LATER PROGRESSED INTO A SECOND DEGREE BURN (BLISTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780713 MEDICHOICE INSTANT WARM PACK PACK, HOT OR COLD, DISPOSABLE IMD OWENS & MINOR DISTRIBUTION, INC. CWP901

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| R NO OTHER THERAPIES