BEUDAMED
    FDA Adverse Event Summary report: N

    CRANE

    MDR report key: 6335756 · Received February 14, 2017

    Report

    Report Number
    MW5067913
    Date Received
    February 14, 2017
    Date of Event
    January 26, 2017
    Report Date
    January 27, 2017
    Manufacturer
    CRANE USA
    Product Code
    KFZ
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY(B)(6) SON STUCK HIS INDEX FINGER IN THE PLASTIC LID OF THE CRANE ULTRASONIC COOL MIST DROP SHAPE HUMIDIFIER AND IT GOT STUCK. HE WAS WITH MY NANNY ALONE AT THE TIME AND TRIED TO GET IT FREE WITH SOAP AND WATER. MY SON WAS QUITE HYSTERICAL WHEN I WALKED IN THE DOOR FROM WORK AND WAS SCREAMING AND CRYING. WE THEN TRIED BOTH VASELINE AND BABY OIL, BUT NOTHING WORKED TO FREE HIS FINGER. WE DECIDED TO CUT THROUGH THE PLASTIC USING KITCHEN SCISSORS. THE PLASTIC WAS TOUGH TO CUT THROUGH, BUT WE WERE FINALLY ABOUT TO CUT ENOUGH PLASTIC TO GIVE THE PLASTIC SOME WIGGLE ROOM TO BEND. AFTER FREEING HIS FINGER (ABOUT 5-7 MINUTES AFTER BEING STUCK), IT WAS RED AROUND THE PART OF THE FINGER, IT WAS STUCK, SWOLLEN AND HAD A SMALL LACERATION WHERE THE PLASTIC LID HAD A LIP. EVEN NOW TWO DAYS LATER, IT IS STILL SWOLLEN AND QUITE RED. (B)(4). PRODUCT CATEGORY: BABY. PRODUCT TYPE: NURSERY EQUIPMENT AND SUPPLIES. RETAILER: (B)(6). RETAILER: STATE: ONLINE. PURCHASE DATE: 10/17/2015, THIS DATE IS AN ESTIMATE. THE PRODUCT WAS DAMAGED BEFORE THE INCIDENT: NO. THE PRODUCT WAS MODIFIED BEFORE THE INCIDENT: NO. I EMAILED THEIR CUSTOMER SERVICE ON THEIR WEBSITE AND PROVIDE DETAILS AROUND THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110839 CRANE CRANE ULTRASONIC COOL MIST DROP SHAPE HUMIDIFIER KFZ CRANE USA

    Patients

    Seq Age Sex Outcome Treatment
    1 13 MO