BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8320260 · Received February 8, 2019

    Report

    Report Number
    1417592-2019-00020
    Event Type
    Injury
    Date Received
    February 8, 2019
    Date of Event
    February 3, 2019
    Report Date
    February 8, 2019
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE HOT PACK BURST DURING ACTIVATION. REPORTEDLY, THE HOT PACK WAS "TWISTED" BY THE USER IN ORDER TO ACTIVATE IT. THE HOT PACK CONTENTS MADE CONTACT WITH THE USER'S SKIN AND SHE EXPERIENCED REDNESS AND A BURNING SENSATION BELOW HER LEFT EAR, ON AN UNIDENTIFIED CHEEK, AND UNDER HER LEFT EYE. THE STAFF MEMBER IMMEDIATELY RINSED HER SKIN WITH WATER AND "APPLIED A WET, COOL CLOTH TO THE AFFECTED AREAS." REPORTEDLY, SHE WENT TO A LOCAL URGENT CARE CENTER WHERE SHE WAS DIAGNOSED WITH "SECOND-DEGREE" BURNS, WAS GIVEN A TETANUS INJECTION, AND WAS PROVIDED WITH BACITRACIN FOR APPLICATION ON THE AFFECTED AREAS. THERE WAS NO REPORTED IMPACT OR ADVERSE EFFECT TO A PATIENT IN RELATION TO THIS INCIDENT. NO SAMPLE WAS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. LABELING ON THE HOT PACK INCLUDES A DOTTED "FOLD ME" LINE AND INSTRUCTS USERS "FOLD TO ACTIVATE." ALTHOUGH A DEFINITIVE ROOT CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED, USER ERROR CANNOT BE RULED OUT AS A CAUSE AND/OR CONTRIBUTING FACTOR. DUE TO THE NEED FOR MEDICAL INTERVENTION, AND IN AN ABUNDANCE OF CAUTION, 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 THE HOT PACK BURST DURING ACTIVATION AND THAT A STAFF MEMBER EXPERIENCED BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113773 PACK,HOT,INSTANT,NON-INSULATED,6"X10" IMD MEDLINE INDUSTRIES INC. CN18310

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R