BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRA COLD PACK

    MDR report key: 3203855 · Received June 27, 2013

    Report

    Report Number
    3203855
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 27, 2013
    Manufacturer
    CARDINAL HEALTH
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ATTEMPTING TO USE A CARDINAL HEALTH INSTANT COLD PACK MEDIUM FOR BACK RELIEF. THE NURSE CARING FOR THE PATIENT AND THE PATIENT'S HUSBAND BOTH SQUEEZED THE COLD PACK AND THE INSIDE CONTENTS WOULD NOT BREAK OPEN FOR ACTIVATION. THE PATIENT THEN SQUEEZED THE BAG AS DIRECTED ON THE PACKAGING. THE BAG BURST OPEN AND THE CONTENTS SPLASHED INTO THE NURSE'S EYES. SHE WAS IMMEDIATELY IRRIGATED AT THE EYE WASH STATION AND TAKEN TO THE IMMEDIATE CARE CENTER WHERE SHE SUSTAINED MINOR EYE IRRITATION BUT NO VISUAL ABNORMALITIES.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?COLD PACK FOR BACK RELIEF OF PATIENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293332 ASTRA COLD PACK PACK, COLD, DISPOSABLE IMD CARDINAL HEALTH * V3B041

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR NO