BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAST PROTECTOR

    MDR report key: 5590596 · Received April 20, 2016

    Report

    Report Number
    1417592-2016-00042
    Event Type
    Injury
    Date Received
    April 20, 2016
    Date of Event
    March 22, 2016
    Report Date
    April 20, 2016
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    KIA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT WHILE USING THE DEVICE ON EACH LEG, THE LEG CASTS BECAME WET AND HAD TO BE REPLACED. THE OPERATIVE SITES WERE NOT AFFECTED. THE SAMPLE WAS RETURNED AND EVALUATED. THE OPENINGS OF BOTH PROTECTORS HAD STRETCH MARKS AROUND IT SUGGESTING THAT BOTH HAD BEEN USED. MOISTURE COULD BE OBSERVED ON THE OUTSIDE OF THE DEVICES BUT NOT ON THE INSIDE. IT IS NOT KNOWN IF THE CAST PROTECTORS WERE APPROPRIATELY APPLIED PRIOR TO USE TO PREVENT WATER FROM ENTERING. THERE WAS NO INDICATION OF A MANUFACTURING DEFECT. A ROOT CAUSE HAS NOT BEEN DETERMINED. DUE TO THE NEED FOR THE CASTS TO BE REPLACED, THIS MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    WHILE USING CAST PROTECTORS BILATERALLY, BOTH OF THE CASTS BECAME WET AND HAD TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243446 CAST PROTECTOR KIA MEDLINE INDUSTRIES, INC. 90115090037

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other