BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GFX NERVE ABLATION SYSTEM

    MDR report key: 1078343 · Received July 17, 2008

    Report

    Report Number
    2135225-2008-00045
    Event Type
    Injury
    Date Received
    July 17, 2008
    Date of Event
    January 12, 2008
    Report Date
    July 17, 2008
    Manufacturer
    BIOFORM MEDICAL INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EYE INFECTION CLEARED UP AFTER THE ANTIBIOTICS WERE ADMINISTERED. THERE IS LIMITED INFO AVAILABLE TO DETERMINE THE EXTENT TO WHICH GFX NERVE ABLATION SYSTEM CONTRIBUTED TO THE PTS EYE INFECTION. THE GFX NERVE ABLATION SYSTEM WAS ACQUIRED BY BIOFORM MEDICAL INC., ON MAY, 2008. THE EVENT OCCURRED PRIOR TO BIOFORMS ACQUISITION.

    Description of Event or Problem · 1

    THE PATIENT WAS GIVEN GFX NERVE ABLATION TREATMENT IN THE TEMPORAL LOBE DURING CLINICAL TRIAL AND DEVELOPED AN EYE INFECTION IN THE LEFT EYE. AFTER THE PROCEDURE, THE PATIENT COULD NOT CLOSE HER LEFT EYE TIGHTLY AND THE EYE BECAME INFECTED. THE PATIENT SAW AN OPHTHALMOLOGIST WHO ADMINISTERED ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GFX NERVE ABLATION SYSTEM LESION PROBE AND GENERATOR SYSTEM GEI BIOFORM MEDICAL INC. RFG-100;PB-100T

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention