BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEROYAL SKIN MARKER

    MDR report key: 1932252 · Received December 3, 2010

    Report

    Report Number
    1060680-2010-00003
    Event Type
    Other
    Date Received
    December 3, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 20, 2010
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    FZZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REQUESTED REGARDING THE REPORTED PT INTERACTION WITH THE SKIN MARKER AND THAT HAS NOT BEEN RECEIVED AS OF THIS REPORT SUBMISSION. THE INCIDENT DEVICE WAS NOT RETURNED FOR INDIVIDUAL EVALUATION; HOWEVER, THE MSDS FOR THE DEROYAL SKIN MARKER DEVICES INDICATES THEY CONTAIN ONLY ISOPROPYL ALCOHOL, PROPYLENE GLYCOL AND GENTIAN VIOLET. ALL THESE INGREDIENTS HAVE A HISTORY OF SUCCESSFUL USE ON HUMAN SKIN WITH THE POSSIBILITY OF SLIGHT SKIN IRRITATION IN INDIVIDUALS WHO MAY BE SENSITIZED TO ONE OR MORE OF THE INGREDIENTS. THIS DEVICE AND ITS PACKAGING ARE KNOWN TO BE LATEX FREE AND WITHOUT ALL THE TEST CRITERIA FROM THE REPORTING FACILITY AND THE FURTHER KNOWLEDGE OF ANY ALLERGIES, THE PT MAY HAVE HAD AT THE TIME OF TESTING, WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE FOR THIS REPORTED REACTION.

    Description of Event or Problem · 1

    THE FACILITY DID A PATCH TEST WITH ONE OF THEIR PTS AND THEY SAW THAT SHE REACTED TO THE STERILE SKIN MARKER. THE SKIN WAS MARKED AND AFTER THE UV RADIATION, THEY SAW ERYTHEMA ON THE PLACES WHERE THE SKIN MARKER WAS USED. THE CUSTOMER HAS ASKED FOR THE COMPOSITION OF THE SKIN MARKER TO DETERMINE TO WHAT THE PT MAY HAVE REACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEROYAL SKIN MARKER SKIN MARKER FZZ DEROYAL INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other