BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAST PROTECTOR

    MDR report key: 3188065 · Received June 17, 2013

    Report

    Report Number
    1417592-2013-00053
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 14, 2013
    Report Date
    June 13, 2013
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    KIA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT WHILE USING THE DEVICE, THE CAST BECAME WET AND THE CAST HAD TO BE REPLACED. THE CAST PROTECTOR WAS RETURNED FOR EVALUATION. THERE WERE NO RIPS, DEFECTS, TEARS OR SEALING ISSUES OF THE MATERIAL. THE ELASTIC OPENING DID NOT DISPLAY ANY SIGNS OF PERMANENT DEFORMATION OR BREAKDOWN. IT IS NOT KNOWN IF THE CAST PROTECTOR WAS SIZED CORRECTLY FOR THE END USER OR IF IT HAD BEEN APPLIED CORRECTLY PRIOR TO USE. THERE WAS NO INDICATION THE INCIDENT WAS CAUSED BY A MANUFACTURING DEFECT. 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
    274617 CAST PROTECTOR KIA MEDLINE INDUSTRIES, INC. 26007083

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention