BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAST AND BANDAGE PROTECTOR

    MDR report key: 4006329 · Received August 6, 2014

    Report

    Report Number
    1417592-2014-00076
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 1, 2014
    Report Date
    August 6, 2014
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    KIA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    APLIGRAF HAD BEEN APPLIED TO A LEFT FOOT WOUND ONE MONTH PRIOR TO THE INCIDENT. LAST MONTH WHILE SHOWERING, THE END USER STATED HE FELT WATER INSIDE THE PROTECTOR. HIS DRESSING BECAME WET AND THE APLIGRAF ON HIS FOOT HAD TO BE REAPPLIED. THE PROTECTOR WAS NOT RETURNED TO USE FOR EVAL. IT IS NOT KNOWN IF IT WAS APPLIED CORRECTLY OR IF THERE WAS ANY DAMAGE TO THE PROTECTOR PRIOR TO OR DURING USE. A ROOT CAUSE HAS NOT BEEN DETERMINED. WE HAVE NOT CONFIRMED THAT A DEFECT EXISTED BUT IN AN ABUNDANCE OF CAUTION THIS MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    THE DRESSING BECAME WET WHILE SHOWERING AND THE APLIGRAF WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459032 CAST AND BANDAGE PROTECTOR KIA MEDLINE INDUSTRIES, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention