BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL

    MDR report key: 3810061 · Received April 4, 2014

    Report

    Report Number
    1060680-2014-00005
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 12, 2014
    Manufacturer
    ADVANCE STORE PRODUCTS
    Product Code
    KDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEROYAL: THE REPORTED PRODUCT WAS NOT RETURNED FOR EVAL AND THERE HAVE BEEN NO PREVIOUS REPORTS OF THIS NATURE FOR THE FINISHED GOOD. THE REPORTING FACILITY WAS CONTACTED FOR FURTHER INFO AND IT WAS FOUND THAT THEY ARE UTILIZING THE PRODUCT BY MARKING A PENROSE DRAIN TO REFERENCE DURING DRESSING CHANGES FOR THE DRAIN TO BE WITHDRAWN 1CM DAILY (OR HOWEVER PRESCRIBED). THEY HAVE FOUND THE PINS TO BEGIN TO RUST AND PRINT ON THE SKIN. AFTER EVAL OF PRODUCT UTILIZATION AND THE LABELING, THE ROOT CAUSE WAS DETERMINED TO BE USER ERROR BY USING THE PRODUCT WITHIN A MOISTURE RICH ENVIRONMENT. THE LABELING STATES TO 'KEEP DRY'.

    Description of Event or Problem · 1

    THE END USER REPORTED THAT THE SAFETY PINS WERE RUSTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204768 DEROYAL INSTRUMENT, MANUAL, SURGICAL, GENERA KDD ADVANCE STORE PRODUCTS 31516368

    Patients

    Seq Age Sex Outcome Treatment
    1 Other