BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENDED COATED BLADE

    MDR report key: 1355780 · Received April 1, 2009

    Report

    Report Number
    1717344-2009-00118
    Event Type
    Injury
    Date Received
    April 1, 2009
    Date of Event
    March 11, 2009
    Report Date
    March 11, 2009
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF INITIAL REPORT: 04/01/2009. THE SITE INFORMED US THE COATED BLADE INCIDENT SAMPLE WAS DISCHARGED AND IS NOT AVAILABLE FOR INVESTIGATION. THE SITE REPORTED THE EXPIRATION DATE OF THE COATED BLADE BUT NOT THE LOT #. THE EXPIRATION DATE CORRESPONDS TO 3 DIFFERENT LOT #S 111988, 112958 AND 113157.

    Description of Event or Problem · 1

    THE REPORT STATED THAT POST-OPERATIVELY, THE STAFF NOTED A WHITE, CHARRED LESION ON RIGHT SIDE OF TONGUE. THEN 10 MINUTES AFTER PATIENT WAS DISCHARGED, AN INJURY WAS NOTED ON THE LEFT SIDE OF THE TONGUE. THE INJURY GREW FROM THE "SIZE OF A DIME" TO THE WHOLE LEFT SIDE OF THE TONGUE. THE SITE DESCRIBED THE BURN ON SIDE OF TONGUE AS THE OUTER ASPECT BEING WHITE AND THE INNER ASPECT WAS BLACKENED. THE INJURY WAS LIMITED TO THE TONGUE. THE PT WAS TREATED WITH 10 MG OF PEDIAPRED FOR FIRST 2 DAYS; THEN 5 MG DAILY THEREAFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENDED COATED BLADE ELECTROSURGICAL ACCESSORY GEI COVIDIEN LP (VALLEYLAB) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other FORCE220PC - ES GENERATOR| E2515H - ELECTROSURGICAL PENCIL