BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELLEVE S5

    MDR report key: 5957299 · Received September 16, 2016

    Report

    Report Number
    2428235-2016-00007
    Event Type
    Injury
    Date Received
    September 16, 2016
    Date of Event
    August 18, 2016
    Report Date
    September 16, 2016
    Manufacturer
    CYNOSURE, INC. DBA ELLMAN
    Product Code
    GEI
    PMA / PMN Number
    K123366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    POST-TREATMENT, A SUTURE AND STERI STRIP WAS APPLIED TO AFFECTED AREA. DEVICE SHOWED NO EVIDENCE OF MALFUNCTION, AND PATIENT MADE FULL RECOVERY FOLLOWING PROCEDURE AND IS DOING WELL.

    Description of Event or Problem · 1

    PATIENT UNDERWENT SURGICAL TREATMENT FOR REMOVAL OF SEBORRHEIC KERATOSIS IN THE ABDOMEN. CUT MODE WAS MISTAKENLY ACTIVATED INSTEAD OF BLEND BY THE TREATMENT PROVIDER, WHICH RESULTED IN A DEEP CUT OF THE TISSUE USING SETTINGS THAT WERE NOT RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608421 PELLEVE S5 PELLEVE S5 GEI CYNOSURE, INC. DBA ELLMAN IEC5P-ST (MOD2)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S