BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8459562 · Received March 28, 2019

    Report

    Report Number
    1417592-2019-00029
    Event Type
    Injury
    Date Received
    March 28, 2019
    Date of Event
    March 7, 2019
    Report Date
    March 28, 2019
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A HOT PACK WAS USED ON A MALE NEONATE PATIENT AND THE PATIENT EXPERIENCED THIRD DEGREE BURNS. PER THE FACILITY, CONTRARY TO MANUFACTURER INSTRUCTIONS, THE HOT PACK WAS ACTIVATED AND PLACED DIRECTLY ON THE PATIENT'S SKIN WITH NO BARRIER FOR APPROX. 12 MINUTES. THE FACILITY STATED THAT THE PACKAGE IS CLEARLY MARKED WITH 'DO NOT USE ON INFANT'; HOWEVER A NEW NURSE ON THE UNIT USED THE HOT PACK ON THE NEWBORN BABY UNDER THE LEFT AND RIGHT LEGS AND LEFT THE HOT PACK DIRECTLY ON THE PATIENTS SKIN RESULTING IN THIRD DEGREE BURNS TO THE AREA OF THE SKIN DIRECTLY UNDER THE HOT PACK. THE FACILITY CONSULTED A SPECIALTY PHYSICIAN FOR BURNS, PROVIDED UNSPECIFIED WOUND CARE AND DEBRIDEMENT. THE SAMPLE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE. THE CUSTOMER CONTACT DID NOT PROVIDE FURTHER PATIENT OR INCIDENT DETAILS TO THE MANUFACTURER. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOT PACK WAS USED ON A NEONATE WITH NO BARRIER RESULTING IN THE NEONATE EXPERIENCING BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252381 PACK,HOT,INSTANT,NON-INSULATED,6"X10" IMD MEDLINE INDUSTRIES INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Required Intervention