BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX INTERNATIONAL

    MDR report key: 3904959 · Received June 5, 2014

    Report

    Report Number
    1717344-2014-00425
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 7, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION DID NOT IDENTIFY ANYTHING THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INVESTIGATION FOUND THAT THE NIT FUNCTIONS NORMALLY AND WITHIN SPECIFICATION. THE CONCOMITANT DEVICES VL2600 AND E7509 WERE NOT RETURNED. .

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PT RECEIVED A 2ND DEGREE BURN TO THE RIGHT GLUTEUS. THE BURN WAS TREATED WITH ANTIBIOTICS AND HEALING PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330272 FORCE FX INTERNATIONAL ELECTROSURGICAL GENERATOR GEI COVIDIEN LP

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR E7509 POLYHESIVE II CORDLESS LOT #: 40410161X| VL2600 DISP PENCIL W/HOLSTER LOT #: 1308161X