BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEROYAL

    MDR report key: 2987939 · Received February 26, 2013

    Report

    Report Number
    2320762-2013-00001
    Event Type
    Other
    Date Received
    February 26, 2013
    Date of Event
    February 2, 2013
    Report Date
    February 5, 2013
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    MGQ
    PMA / PMN Number
    K952775
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT MULTIDEX GEL WAS APPLIED TO INCISION ON SACRAL AREA FROM A CYST BEING REMOVED AND PRODUCT RIPPED BUTT CHEEKS CAUSING BLEEDING. DEROYAL: WITHIN THE APPLICATION SECTION OF THE INSTRUCTIONS FOR USE IT STATES TO COVER WITH A NON-ADHERENT DRESSING AFTER APPLYING THE MULTIDEX. THIS EVENT WAS DETERMINED TO BE AN APPLICATION ERROR. THE CUSTOMER OBTAINED THE PRODUCT FROM AN OUTSIDE SOURCE AND IT IS UNK TO DEROYAL IF THE IFU WAS SUPPLIED TO THE TIME OF PURCHASE. AS A CORRECTIVE ACTION IT WAS CONFIRMED THAT AN IFU WAS PROVIDED WITH THE REPLACEMENT PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIDEX GEL WAS APPLIED TO INCISION ON SACRAL AREA FROM A CYST BEING REMOVED AND PRODUCT RIPPED BUTT CHECKS CAUSING BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81121 DEROYAL MGQ - DRESSING, WOUND AND BURN MGQ DEROYAL INDUSTRIES, INC. 27962701

    Patients

    Seq Age Sex Outcome Treatment
    1 Other