BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARGYLE INFANT HEEL WARMER

    MDR report key: 3904457 · Received June 9, 2014

    Report

    Report Number
    3904457
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    June 7, 2014
    Report Date
    June 9, 2014
    Manufacturer
    COVIDIEN
    Product Code
    MPO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US

    Narratives

    Description of Event or Problem · 1

    THE NURSE PICKED UP AN INFANT HEEL WARMER AND PROCEEDED BACK TO THE INFANT TO USE THE DEVICE. WHILE WALKING BACK TO THE BASINETTE, THE NURSE BEGAIN APPLYING LIGHT PRESSURE TO THE PACK TO BEGIN THE MIXING OF THE WARMING CHEMICALS. THE NURSE STATES SHE USED VERY LITTLE PRESSURE AND THE PACK EXPLODED AND SPRAYED HER IN THE EYES WITH THE CHEMICAL. THE FORCE WAS GREAT ENOUGH TO PRODUCE SPLATTER ON THE CEILING IN ABOUT A 3' RADIUS. THE NURSE RECEIVED MEDICAL TREATMENT BECAUSE OF EYE BURNING. SHE WAS GIVEN ERYTHROMYCIN FOR HER EYES AND WAS SENT HOME. THE PACKAGING WASN'T SAVED HOWEVER THE REMAING LOT WAS REMOVED FROM SERIVCE. WE PULLED TWO CASES OUT OF USE AND THE MANUFACTURER IS ONLY REQUESTING A FEW PACKS FOR SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336003 ARGYLE INFANT HEEL WARMER PACK, HOT OR COLD, DISPOSABLE MPO COVIDIEN MH00002T 321826X
    336004 ARGYLE INFANT HEEL WARMER PACK, HOT OR COLD, DISPOSABLE MPO COVIDIEN MH00002T 321826X
    336005 ARGYLE INFANT HEEL WARMER PACK, HOT OR COLD, DISPOSABLE MPO COVIDIEN MH00002T 321826X
    336006 ARGYLE INFANT HEEL WARMER PACK, HOT OR COLD, DISPOSABLE MPO COVIDIEN MH00002T 321826X

    Patients

    Seq Age Sex Outcome Treatment
    1 * EVENT DIDN'T INVOLVE A PATIENT