BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LITTLE HOTTIES HAND WARMERS

    MDR report key: 2021644 · Received March 11, 2011

    Report

    Report Number
    MW5019786
    Event Type
    Injury
    Date Received
    March 11, 2011
    Date of Event
    February 5, 2011
    Report Date
    March 9, 2011
    Manufacturer
    IMPLUS FOOTCARE, LLC.
    Product Code
    IMD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    MY CLIENT, (B)(6) WAS USING HAND WARMERS MANUFACTURED BY IMPLUS FOOTCARE, LLC. THE NAME OF THE PRODUCT WAS "LITTLE HOTTIES HAND WARMERS". WE BELIEVE THE MODEL NUMBER WAS LHW1-3BT. SHE WAS USING THEM AS DIRECTED TO KEEP HER HANDS WARM AT AN OUTDOOR SPORTS EVENT. AFTER USING THEM FOR A FEW HOURS, SHE REMOVED HER GLOVE (WHICH CONTAINED A LITTLE HOTTIE PACKET), AND PLACED HER GLOVE WITH THE LITTLE HOTTIE PACKET INSIDE OF IT, INTO HER BACK POCKET. SHE WAS WEARING KHAKI PANTS WITH NOTHING ELSE IN HER BACK POCKET. ALMOST IMMEDIATELY, THEREAFTER, THE PACKET SPONTANEOUSLY IGNITED, CATCHING HER ON FIRE. NEARBY WITNESSES POURED WATER ON HER TO PUT OUT FLAMES. SHE SUSTAINED 2ND AND 3RD DEGREE BURNS TO HER BUTTOCKS, INNER THIGHS, VAGINAL AREA, AND LOWER BACK. SHE WAS HOSPITALIZED FOR ABOUT ONE WEEK, AND HAS HAD FREQUENT MEDICAL CARE SINCE THAT TIME. SHE IS UNDER THE CARE OF A PLASTIC SURGEON AT THIS TIME. NOTE: THE PACKET THAT CAUSED HER BURNS OBVIOUSLY BURNED IN THE INCIDENT. HOWEVER, I, AS HER ATTORNEY, DO HAVE THE BOX, THE PACKET CAME FROM ALONG WITH REMAINING PACKETS (THE PRODUCT WAS SOLD IN A LARGE BOX, CONTAINING 40 PACKETS INSIDE). I HAVE PHOTOS OF HER SERIOUS INJURIES, IF THE FDA WOULD LIKE TO SEE THE DAMAGE CAUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LITTLE HOTTIES HAND WARMERS HAND WARMERS IMD IMPLUS FOOTCARE, LLC. LHW1-3BT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| S