BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI HAO KI LAN BANDAID

    MDR report key: 2428319 · Received January 19, 2012

    Report

    Report Number
    MW5023927
    Event Type
    Injury
    Date Received
    January 19, 2012
    Date of Event
    January 19, 2012
    Report Date
    January 19, 2012
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    FQM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    I PUT A CHILDREN'S HAO KAI LAN SQUARE BANDAID ON A SCRATCH ON MY DAUGHTER'S LEG A COUPLE OF DAYS AGO. THIS PRODUCT IS THE BAND-AID NI HAO KAI-LAN BANDAGES-20 CT BY BAND-AID. WHEN MY DAUGHTER TOOK A BATH TONIGHT, THE BANDAID CAME OFF AND WE SAW A HORRIBLE INFLAMED AND BLISTERED SQUARE WHERE THE ADHESIVE OF THE BANDAID HAD BEEN. THIS IS THE FIRST AND ONLY TIME THAT MY DAUGHTER HAD A REACTION TO A BANDAID ADHESIVE. I TOOK A COUPLE OF PICTURES TO RECORD THIS, BUT I DON'T HAVE A MACRO LENS ON MY CAMERA. SO THEY ARE A BIT BLURRY. ONE CAN CLEARLY SEE A SKIN REACTION AND I CAN SEND THESE BY EMAIL IF YOU CONTACT ME AT (B)(6). I BELIEVE THAT THIS BANDAID MUST HAVE AN ADHESIVE MATERIAL DIFFERENT FROM WHAT IS COMMONLY USED. THE CO NEEDS TO BE NOTIFIED AND THEIR PRODUCTS INSPECTED. UNFORTUNATELY, I CANNOT FIND THE BOX FROM WHICH THE BANDAID CAME, BUT I DID SAVE THE USED BANDAID, IF THAT WILL HELP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI HAO KI LAN BANDAID BANDAID FQM JOHNSON & JOHNSON NI HAO KAI LAN BANDAID

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR BAND-AID NI HAO KAI-LAN BANDAGES: 20 CT| BY BAND-AID