BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDESAFE HANDPIECE

    MDR report key: 2556359 · Received April 26, 2012

    Report

    Report Number
    2428235-2012-00006
    Event Type
    Injury
    Date Received
    April 26, 2012
    Date of Event
    November 1, 2011
    Report Date
    March 30, 2012
    Manufacturer
    ELLMAN INT'L, INC.
    Product Code
    GEI
    PMA / PMN Number
    K102698
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING SKIN TIGHTENING PROCEDURE DEMO WITH THE PHYSICIAN, A SMALL BURN WAS SUSTAINED ON THE PATIENT'S FOREHEAD. THE BURN DEVELOPED INTO A BLISTER NEXT DAY. THE BLISTER RESOLVED AND PATIENT WAS LEFT WITH SMALL SCAR SIMILAR TO CHICKEN-POX SCAR, THE SIZE OF A PENCIL ERASER. MEDICAL INTERVENTION WAS NOT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLIDESAFE HANDPIECE GEI ELLMAN INT'L, INC. P210HPDU 39891

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability