BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUTRAL PAD

    MDR report key: 5506386 · Received March 16, 2016

    Report

    Report Number
    2428235-2016-00003
    Event Type
    Injury
    Date Received
    March 16, 2016
    Date of Event
    February 16, 2016
    Report Date
    March 16, 2016
    Manufacturer
    CYNOSURE, INC. DBA ELLMAN
    Product Code
    GEI
    PMA / PMN Number
    K123366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS EVALUATED AND FOUND TO BE OPERATING WITHIN SPECIFICATIONS. THIS TYPE OF BURN IS CONSISTENT WITH THE GROUND PAD NOT BEING APPLIED PROPERLY TO THE PATIENT BY THE USER.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A PROCEDURE WHICH REQUIRED THE USE OF A NEUTRAL PAD. PATIENT INDICATED NO IMMEDIATE PAIN OR DISCOMFORT DURING PROCEDURE. AFTER THE PROCEDURE BURNS, SWELLING, AND REDNESS TO THE UPPER BACK AT THE AREA OF PLACEMENT OF THE NEUTRAL PAD WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162218 NEUTRAL PAD NEUTRAL PAD GEI CYNOSURE, INC. DBA ELLMAN IEC-NPD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other