BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCKESSON MEDI-PAK

    MDR report key: 2268959 · Received August 1, 2011

    Report

    Report Number
    1451040-2011-00003
    Event Type
    Injury
    Date Received
    August 1, 2011
    Date of Event
    May 23, 2011
    Report Date
    August 1, 2011
    Manufacturer
    SHANGHAI INTCO MEDICAL SUPPLY, CO., LTD.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO US THAT A PT RECEIVED A SECOND DEGREE BURN WHILE USING HEAT PACK. WE WERE TOLD BY THE INITIAL REPORTER THAT THE LABEL INSTRUCTIONS TO WRAP THE PACK IN A CLOTH OR TOWEL WERE NOT FOLLOWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCKESSON MEDI-PAK INSTANT HOT COMPRESS IMD SHANGHAI INTCO MEDICAL SUPPLY, CO., LTD. 16-9706 961085

    Patients

    Seq Age Sex Outcome Treatment
    1 Other