BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROCKERSWITCH PENCIL

    MDR report key: 1812000 · Received August 17, 2010

    Report

    Report Number
    1717344-2010-00565
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    July 20, 2010
    Report Date
    August 3, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PT DURING A TONSILLECTOMY AND ADENOIDECTOMY, EXPERIENCED A FULL THICKNESS BURN ON THE LIPS. THE SURGEON ALLEGES THIS RESULTED FROM A FAULTY JUXTAPOSITION OF THE SHAFT AND THE INSULATION. THE REPORTER STATED THAT SHE THOUGHT THERE MAY HAVE BEEN USER ERROR INVOLVED. THE PT WAS ORIGINALLY TREATED WITH SILVADENE AND THE PT IS CURRENTLY SEEING A PLASTIC SURGEON AND IT IS UNCERTAIN IF A SKIN GRAFT IS GOING TO BE REQUIRED OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROCKERSWITCH PENCIL ELECTROSURGICAL ACCESSORY GEI COVIDIEN LP (VALLEYLAB) 186149

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other (B)(4)| FORCEFXC - ELECTROSURGICAL GENERATOR