BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AARON

    MDR report key: 416575 · Received September 9, 2002

    Report

    Report Number
    1030322-2002-00012
    Event Type
    Malfunction
    Date Received
    September 9, 2002
    Date of Event
    July 1, 2002
    Report Date
    July 22, 2002
    Manufacturer
    AARON MEDICAL INDUSTRIES
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT THAT INSULATION HAD BROKEN DOWN ON THE BLACK PART OF THE ES39. THIS RESULTED IN AN UNWANTED BURN TO THE TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AARON DISPOSABLE ELECTRODE-EXTENDED MODIFIED BLADE GEI AARON MEDICAL INDUSTRIES ES39 2001-11-02

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other