BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUCTION COAGULATOR 10 FR-6"

    MDR report key: 1672284 · Received April 30, 2010

    Report

    Report Number
    1717344-2010-00280
    Event Type
    Injury
    Date Received
    April 30, 2010
    Date of Event
    March 26, 2010
    Report Date
    March 31, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    DWG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE INCIDENT DEVICE WAS DISCARDED BY THE CUSTOMER AND IS NOT AVAILABLE FOR EVAL. IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT FOLLOWING AN ADENOTONSILLECTOMY PROCEDURE, THE DR NOTICED BURNS ON THE PT IN THE AREAS OF THE LOWER LIP AND MOUTH, LEFT SIDE OF TONGUE, AND LEFT SIDE OF THE CHIN. THE BURNS WERE IN THE SHAPE OF THE (B) (4) RETRACTOR. THE PT HAD TO BE ADMITTED. SURGICAL REPAIR MAY BE NECESSARY. THE SURGEON INADVERTENTLY PRESSED THE ACTIVATION BUTTON WHILE TRYING TO COVER THE SUCTION HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUCTION COAGULATOR 10 FR-6" ELECTROSURGICAL ACCESSORY DWG COVIDIEN LP (VALLEYLAB) 149740

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other| R