BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOSENSE WEBSTER STOCKERT 70 RF GENERATOR

    MDR report key: 739832 · Received July 24, 2006

    Report

    Report Number
    9612355-2006-00049
    Event Type
    Other
    Date Received
    July 24, 2006
    Date of Event
    June 28, 2006
    Report Date
    July 24, 2006
    Manufacturer
    STOCKERT GMBH
    Product Code
    GXD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED BURN AT THE RF GROUNDING PATCH SITE WHEN USING 8MM CATHETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER STOCKERT 70 RF GENERATOR RADIOFREQUENCY GENERATOR GXD STOCKERT GMBH STOCKERT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other