BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROSIL

    MDR report key: 666024 · Received January 20, 2006

    Report

    Report Number
    2515379-2005-00540
    Event Type
    Injury
    Date Received
    January 20, 2006
    Date of Event
    February 15, 2005
    Report Date
    December 23, 2005
    Manufacturer
    *
    Product Code
    EBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A PT CLAIMS TO HAVE DEVELOPED A RASH, PIMPLES, BURNING SENSATIONS, AND LATER SORES/LESIONS ON THE FACE IN THE AREA WHERE HYDROSIL XT CONTACTED THE SKIN DURING AN IMPRESSION PROCEDURE. THE PT NOTED THE SYMPTOMS BEGAN TO DEVELOP A SHORT TIME AFTER THE PROCEDURE AND HAD BEEN PRESENT FOR APPROX TEN MONTHS AT THE TIME THE EVENT WAS REPORTED. TWO DOCTORS WERE CONSULTED AND THE PT WAS ADMINISTERED ANTIBIOTICS, STEROIDS, AND A BURN CREAM TO TREAT THE SYMPTOMS. ADDITIONALLY, A BIOPSY WAS PERFORMED ON THE AREA AND THE SYMPTOMS CLASSIFIED AS A "CHEMICAL/SUN IRRITATION REACTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROSIL * EBH * NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention