BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDART

    MDR report key: 2677761 · Received July 18, 2012

    Report

    Report Number
    8021543-2012-04426
    Event Type
    Other
    Date Received
    July 18, 2012
    Date of Event
    October 28, 2009
    Report Date
    June 6, 2012
    Manufacturer
    MEDART A/S
    Product Code
    GEX
    PMA / PMN Number
    K993815
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NEVER REPORTED TO HAVE FAILED. THE USER DECIDED NOT TO SEND IN THE PRODUCT FOR EVAL BY MEDART. THE INSPECTION BY THE USER DID NOT FIND ANY FAILURES TO THE DEVICE. THE DEVICE WAS FOUND TO PERFORM ACCORDING TO SPECS. THE OPERATOR WAS REPORTING THIS DUE TO THE INITIAL RESPONSE FROM THE PT.

    Description of Event or Problem · 1

    PT CLAIM TO HAVE RECEIVED BRUISING AFTER HAIR REMOVAL UPON UPPER LIP. THE DOCTOR DID REDUCE ENERGY UNDER NORMAL LEVEL DURING THIS PROCEDURE AS SHE WAS CONCERNED ABOUT THE PT REACTION. THE PT REACTED ANYHOW STRONGLY. AFTER A WHILE (MONTHS), THE BRUISING HAS DISAPPEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDART MEDART 435 WITH MEDART 413 GEX MEDART A/S 435.000 + 413.000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention