BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTAHEET INSTANT HOT PACKS, DISPOSABLE

    MDR report key: 4741747 · Received March 10, 2015

    Report

    Report Number
    4741747
    Event Type
    Malfunction
    Date Received
    March 10, 2015
    Report Date
    March 9, 2015
    Manufacturer
    NORTECH LABS, INC
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INSTAHEET INSTANT HOT PACKS, DISPOSABLE, ARE EXCEEDING THE LABELED MAXIMUM TEMP OF 160 DEGREES FAHRENHEIT, AND HAVE REACKED TEMPS AS HIGHT AS 180 DEGREES. THIS POSED A PROBLEM FOR THE PTS WHO ARE UNDER ANESTESIA, I.E., LABOR AND DELIVERY PTS WHO HAVE AN EPIDURAL'S. THE PT CANNOT FEEL IF THEY ARE GETTING BURNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163692 INSTAHEET INSTANT HOT PACKS, DISPOSABLE HOTPACK IMD NORTECH LABS, INC 6530-00-NIB-0209 521610

    Patients

    Seq Age Sex Outcome Treatment
    1