BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 13859146 · Received March 23, 2022

    Report

    Report Number
    1417592-2022-00044
    Event Type
    Injury
    Date Received
    March 23, 2022
    Date of Event
    December 23, 2021
    Report Date
    March 22, 2022
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED BY THE FACILITY THAT THE HOT PACK WAS PLACED DIRECTLY ON THE INFANT'S RIGHT LOWER LEG FOR VASODILATION FOR APPROXIMATELY 15 MINUTES PRIOR TO IV PLACEMENT AND WHEN THE HOT PACK WAS REMOVED A BURN WAS NOTICED ON THE PATIENT'S SKIN UNDERNEATH THE HOT PACK. THE REPORTER STATED THAT THE BURN APPEARED TO BE A BLISTER THAT EVOLVED INTO A DEEP PARTIAL THICKNESS BURN REQUIRING 'MEDICAL BURN TREATMENT, OINTMENT, DRESSING CHANGES, WOUND CARE FOLLOW UP AFTER DISCHARGE AND MEDICATIONS FOR PAIN MANAGEMENT' THE BURN IS REPORTEDLY HEALING. THE HOT PACK WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS THE DEVICE IS NOT TO BE PLACED DIRECTLY ON THE SKIN. THE ROOT CAUSE OF THE CUSTOMER REPORTED ISSUE WAS DETERMINED TO BE USER ERROR. NO ADDITIONAL INFORMATION IS AVAILABLE. 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 · 0

    IT WAS REPORTED BY THE FACILITY THAT THE HOT PACK WAS PLACED DIRECTLY ON THE INFANT'S RIGHT LOWER LEG FOR APPROXIMATELY 15 MINUTES PRIOR TO IV PLACEMENT FOR VASODILATION AND WHEN THE HOT PACK WAS REMOVED A BURN WAS NOTICED ON THE PATIENT'S SKIN UNDERNEATH THE HOT PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517629 PACK,HOT,INSTANT,NON-INSULATED,6X10 IMD MEDLINE INDUSTRIES LP

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Female Required Intervention