BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAST PROTECTOR

    MDR report key: 4196863 · Received October 16, 2014

    Report

    Report Number
    1417592-2014-00095
    Event Type
    Injury
    Date Received
    October 16, 2014
    Date of Event
    September 24, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    KIA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT WHILE USING THE DEVICE, THE LEG CAST BECAME WET AND HAD TO BE REPLACED. SOME SKIN IRRITATION OF THE HEEL WAS NOTED WHEN THE ORIGINAL CAST WAS REMOVED. THE END USER'S MOTHER TESTED THE CAST PROTECTOR FOR LEAKS FOLLOWING THE INCIDENT AND NONE WERE FOUND. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. WE HAVE NO LOT NUMBER. A SAMPLE WAS PULLED FROM STOCK AND EVALUATED. NO ABNORMALITIES WERE IDENTIFIED. IT IS NOT KNOWN IF THE TOP OPENING OF THE CAST PROTECTOR WAS APPROPRIATELY SECURED PRIOR TO USE TO PREVENT WATER FROM ENTERING. THERE IS NO INDICATION THAT THE INCIDENT WAS CAUSED BY A MANUFACTURING DEFECT. WITHOUT THE ACTUAL SAMPLE A ROOT CAUSE HAS NOT BEEN CONFIRMED. DUE TO THE NEED FOR THE CAST TO BE REPLACED, THIS MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    WHILE USING THE CAST PROTECTOR, THE CAST BECAME WET AND HAD TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658061 CAST PROTECTOR KIA MEDLINE INDUSTRIES, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other