BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICHOICE WARM PACK

    MDR report key: 2071881 · Received April 23, 2011

    Report

    Report Number
    MW5020392
    Event Type
    Injury
    Date Received
    April 23, 2011
    Date of Event
    March 24, 2011
    Report Date
    April 23, 2011
    Manufacturer
    OWENS AND MINOR
    Product Code
    IMD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WARM PACK APPLIED TO PT'S NECK INSIDE MFR PROVIDED PROTECTIVE SLEEVE. THIRTY MINUTES LATER, PT FOUND TO HAVE PARTIAL THICKNESS BURN THE SIZE OF THE WARM PACK (SKIN RED AND BLISTERED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICHOICE WARM PACK NONE IMD OWENS AND MINOR REORDER #1480069901

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Other