BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE MPX

    MDR report key: 6228834 · Received January 6, 2017

    Report

    Report Number
    1222993-2017-00001
    Event Type
    Malfunction
    Date Received
    January 6, 2017
    Date of Event
    December 6, 2016
    Report Date
    January 6, 2017
    Manufacturer
    CYNOSURE INC
    Product Code
    GEX
    PMA / PMN Number
    K091169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS GIVEN TOPICAL POLYSPORIN FOR POST TREATMENT CARE HEALING. THE TREATMENT TECHNIQUE WAS NOT FOLLOWED PER CLINICAL GUIDELINES. BLISTERS/ERYTHEMA ARE EXPECTED SIDE EFFECTS FROM LASER TREATMENTS. THE DEVICE WAS EVALUATED AND FOUND TO BE OPERATING OUTSIDE OF SPECIFICATION (ON HIGHER END), BEYOND THE +/-20% ALLOWED RANGE. CYNOSURE'S SERVICE TECHNICIAN PERFORMED SYSTEM CALIBRATIONS AND MAINTENANCE IN ORDER TO RESOLVE THE ISSUE. THIS IS REPORTABLE BECAUSE THE DEVICE WAS OPERATING OUT OF SPECIFICATION RANGE IN THIS EVENT.

    Description of Event or Problem · 1

    PATIENT DEVELOPED BLISTERS AND ERYTHEMA, EXPECTED SIDE EFFECTS FROM LASER PROCEDURES. BUT, THE DEVICE WAS FOUND OPERATING BEYOND SPECIFICATION RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11199 ELITE MPX ELITE MPX GEX CYNOSURE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other