BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMFORT WARM

    MDR report key: 3082112 · Received April 12, 2013

    Report

    Report Number
    3082112
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 12, 2013
    Manufacturer
    HOSPITAL MARKETING SERVICES, CO, INC
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A WARM PACK LEAKED ON ACTIVATION ON PATIENT AND BED. WE HAVE HAD SEVERAL SUCH EVENTS WITH THESE PACKS.======================MANUFACTURER RESPONSE FOR WARM PACK, INSTANT WARM BACK (PER SITE REPORTER).======================NOT KNOWN, WE ARE PULLING THIS PRODUCT FROM ALL OUR PATIENT AREAS SINCE WE HAVE HAD SEVERAL INSTANCES OF FAILURE AND LEAKING.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?COMFORT MEASURE FOR PATIENT IN PAIN.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158856 COMFORT WARM PACK, HOT OR COLD IMD HOSPITAL MARKETING SERVICES, CO, INC * 8871-3

    Patients

    Seq Age Sex Outcome Treatment
    1 *