BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SSURGITRON

    MDR report key: 2556360 · Received April 26, 2012

    Report

    Report Number
    2428235-2012-00004
    Event Type
    Injury
    Date Received
    April 26, 2012
    Report Date
    March 28, 2012
    Manufacturer
    ELLMAN INT'L, INC.
    Product Code
    GEI
    PMA / PMN Number
    K955167
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE CANNOT BE DETERMINED, HOWEVER, SERIAL NUMBER PLACES IT (B)(4). MANUFACTURER'S ATTEMPTS TO GET ADDITIONAL INFORMATION CONCERNING TREATMENT AND SEVERITY OF PATIENT'S INJURIES WERE UNSUCCESSFUL. WE WERE TOLD THAT THE SURGITRON WAS PURCHASED FROM A RE-SELLER OF REFURBISHED MEDICAL EQUIPMENT, AND NOT FROM THE MANUFACTURER OR AN AUTHORIZED DISTRIBUTOR OF THE MANUFACTURER.

    Description of Event or Problem · 1

    DURING TREATMENT WITH SURGITRON FFPF, WOMAN WAS BURNED. MANUFACTURER ONLY BECAME AWARE OF THIS ADVERSE EVENT WHEN PRACTICE REQUESTED OPERATOR'S MANUAL AND MENTIONED THEY WERE BEING USED FOR A BAD PATIENT OUTCOME THAT RESULTED IN PATIENT BEING BURNED DURING A TREATMENT THAT TOOK PLACE 'A COUPLE OF YEARS AGO'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SSURGITRON GEI ELLMAN INT'L, INC. FFPF

    Patients

    Seq Age Sex Outcome Treatment
    1