BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PACK,HOT,INSTANT,NON-INSULATED,6"X10"

    MDR report key: 8738081 · Received June 26, 2019

    Report

    Report Number
    1417592-2019-00086
    Event Type
    Injury
    Date Received
    June 26, 2019
    Date of Event
    June 3, 2019
    Report Date
    June 26, 2019
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE HOT PACK BURST DURING ACTIVATION. REPORTEDLY, THE PATIENT ACTIVATED THE HOT PACK "WITH A TWISTING MOTION." THE HOT PACK CONTENTS MADE CONTACT WITH THE PATIENT'S UPPER CHEST AND LEFT HAND. THESE AREAS WERE REPORTEDLY FLUSHED WITH WATER. THE PATIENT EXPERIENCED A BURN TO HER UPPER CHEST. SHE REQUIRED ALLOGRAFT PLACEMENT AND UNIDENTIFIED PAIN MEDICATION. A SAMPLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND A FINGER NAIL HOLE WAS IDENTIFIED TO THE TOP OF THE HOT PACK. LABELING ON THE HOT PACK INCLUDES A DOTTED LINE AND INSTRUCTIONS STATING THAT THE HOT PACK IS ACTIVATED BY FOLDING IT IN HALF. DUE TO THE REPORTED NEED FOR MEDICAL INTERVENTION, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ACTIVATION, THE HOT PACK BURST AND THE PATIENT EXPERIENCED A BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531496 PACK,HOT,INSTANT,NON-INSULATED,6"X10" IMD MEDLINE INDUSTRIES INC. CN19050

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention