BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTAHEET INSTANT HOT PACK

    MDR report key: 4609389 · Received March 11, 2015

    Report

    Report Number
    MW5041467
    Event Type
    Injury
    Date Received
    March 11, 2015
    Date of Event
    February 26, 2015
    Report Date
    March 11, 2015
    Manufacturer
    NORTECH LABORATORIES, INC.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    USE OF INSTAHEET INSTANT HOT PACK RESULTED IN 2ND DEGREE BURNS, INCLUDING AN 8 CM BLISTER TO PATIENT'S SKIN. PRODUCT WAS APPLIED TO PATIENT'S ABDOMEN IN AN ATTEMPT TO RELIVE POST-OPERATIVE PAIN. THE PATIENT'S HOSPITAL GOWN WAS USED AS A BARRIER BETWEEN THE PRODUCT AND THE PATIENT'S SKIN. THE PATIENT WAS DISCHARGED TO HOME FROM THE AMBULATORY PROCEDURE UNIT, BUT RETURNED TO THE EMERGENCY MEDICINE DEPARTMENT LATER THE SAME DAY WITH THE BURN AND BLISTER. THE DIAGNOSIS OF 2ND DEGREE BURN WAS ATTRIBUTED TO THE HEAT PACK AFTER MEDICAL STAFF CONFIRMED THERE WERE NO ASPECTS OF THE SURGICAL PROCEDURE THAT COULD HAVE LED TO THE BURN. PER PRODUCT LABELING AND MANUFACTURER WEBSITE, PRODUCT CAN REACH TEMPERATURES AS HIGH AS 149-160 DEGREE FAHRENHEIT. ALTHOUGH THE PRODUCT'S EXTERNAL TEMPERATURE WAS NOT MEASURED, CLINICAL STAFF REPORTED HOTPACKS OF THE SAME MODEL BECAME TOO HOT TO HOLD IN THEIR UNPROTECTED HAND. ALTHOUGH THE BURN WAS NOT DISCOVERED UNTIL AFTER THE PATIENT WAS DISCHARGED, IT IS ASSUMED THAT IF THE HEAT PACK WAS REMOVED EARLIER, THE EXTENT OF THE BURN COULD HAVE BEEN DECREASED. ROUTE: TOPICAL. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED?: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166390 INSTAHEET INSTANT HOT PACK DISPOSABLE INSTANT HOT PACK IMD NORTECH LABORATORIES, INC. TKINST68H

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR ONDANSETRON 4 MG IVP X 1| ACETAMINOPHEN 1000 MG IV X 1| FENTANYL 50 MCG IVP X 2| IBUPROFEN 800 MG IV X 1| HYDROMORPHONE 0.4 MG IV X 3