BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENFAMIL LIPIL REUSABLE ICE PACK

    MDR report key: 1352029 · Received March 18, 2009

    Report

    Report Number
    MW5010494
    Event Type
    Injury
    Date Received
    March 18, 2009
    Date of Event
    February 27, 2009
    Report Date
    February 28, 2009
    Manufacturer
    POLAR TECH, INC
    Product Code
    IME
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OUR DAUGHTER HAD A BABY AT HOSPITAL IN 2009. WHEN SHE WAS RELEASED, THEY GAVE HER A NEW-MOTHER PACKAGE THAT INCLUDED SOME REUSABLE ICE PACKS THAT WERE INTENDED TO KEEP BABY FORMULA COLD. LAST NIGHT, ONE OF THE ICE PACKS LEAKED ONTO OUR KITCHEN COUNTER. WHEN REP WIPED UP THE LIQUID FROM THE ICE PACK, THE LIQUID BURNED THE SKIN ON HER HANDS. SHE PUT ON GLOVES TO FINISH WIPING THE COUNTER. LATER, MY WIFE NOTICED THAT THE LIQUID FROM THE GEL PACK HAD LEFT A FILM ON THE COUNTER. WHEN SHE TRIED TO WIPE UP THE FILM, IT BURNED HER HANDS. THE GEL PACK SAYS "ENFAMIL LIPIL" ON THE FRONT AND WAS MANUFACTURED BY INC. IT SPECIFIES ON THE PACKAGE THAT IT IS INTENDED FOR USE WITH ENFAMIL FORMULA. IF IT WILL BURN ADULT SKIN, IT MIGHT BE VERY DANGEROUS IF IT LEAKED ONTO AN INFANT'S BOTTLE. DOSE: NA. DATES OF USE: 2009. DIAGNOSIS: TO COOL BABY FORMULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENFAMIL LIPIL REUSABLE ICE PACK NA IME POLAR TECH, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other