BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSTANT COLD PACK

    MDR report key: 2253196 · Received September 8, 2011

    Report

    Report Number
    1417592-2011-00050
    Event Type
    Other
    Date Received
    September 8, 2011
    Date of Event
    August 18, 2011
    Report Date
    September 6, 2011
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE END USER PLACED A "SINGLE USE" COLD PACK IN THE FREEZER AND REUSED IT. HE FELL ASLEEP AND IT SHIFTED DURING THE NIGHT. WHEN HE WOKE UP, IT WAS DIRECTLY ON HIS SKIN. HE SUFFERED SECOND DEGREE BURNS. THE PACK WAS INTACT. IT DID NOT LEAK. HE ACKNOWLEDGED THAT HE WAS AWARE IT SHOULD NOT HAVE BEEN REUSED. THE PACKAGING CLEARLY STATES "SINGLE USE ONLY. DO NOT REUSE. DO NOT PLACE DIRECTLY ON SKIN." THE BURN WAS TREATED WITH AN OINTMENT AND COVERED WITH A DRESSING. USER ERROR CAUSED THIS INCIDENT. NO CORRECTIVE ACTION IS INDICATED. DUE TO THE REPORTED BURN, THIS MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    A SINGLE USE COLD PACK WAS PLACED IN THE FREEZER AND REUSED. THE END USER FELL ASLEEP AND SUFFERED A SECOND DEGREE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSTANT COLD PACK NONE IMD MEDLINE INDUSTRIES, INC. MDS137000 104836066

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention