BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH 200 LLC.

    MDR report key: 7826110 · Received August 29, 2018

    Report

    Report Number
    7826110
    Event Type
    Malfunction
    Date Received
    August 29, 2018
    Date of Event
    July 26, 2018
    Report Date
    July 31, 2018
    Manufacturer
    CARDINAL HEALTH 200, LLC.
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT APPROACHED THIS RN AND STATED THAT INSTANT HOT PACK EXPLODED ON HER STOMACH. UPON ASSESSMENT, THIS RN NOTED PATIENT TO HAVE CONTENTS OF HOT PACK OVER HER ARMS AND STOMACH. RN INSTRUCTED PATIENT TO WASH EFFECTED BODY PARTS WITH SOAP AND WATER PER THE PACKAGES INSTRUCTIONS. RN NOTED HOT PACK TO HAVE A SMALL TEAR IN THE BOTTOM OF THE PACKAGE. RN ASKED IF PATIENT HAD BEEN LYING ON THE HEAT PACK, PATIENT STATED THAT HOT PACK WAS BEING USED ON TOP OF HER STOMACH WITHOUT APPLYING PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668271 CARDINAL HEALTH 200 LLC. PACK, HOT OR COLD, DISPOSABLE IMD CARDINAL HEALTH 200, LLC. V7A258

    Patients

    Seq Age Sex Outcome Treatment
    1