BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REUSABLE SUCTION DEVICE

    MDR report key: 2641739 · Received June 28, 2012

    Report

    Report Number
    3007037347-2012-00001
    Event Type
    Injury
    Date Received
    June 28, 2012
    Report Date
    June 28, 2012
    Manufacturer
    INVUITY INC.
    Product Code
    JOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO MFR AND COULD NOT BE EVALUATED. DEVICE WAS NOT USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, WHICH CAUTIONS TO AVOID POSITIONING THE FACE OF THE ILLUMINATION TIP LESS THAN A HALF INCH AWAY FROM SKIN OR TISSUE TO AVOID THERMAL INJURY. DEVICE IS OBSOLETE, IS NO LONGER MANUFACTURED OR DISTRIBUTED, AND ANY REMAINING DEVICES WILL BE REMOVED FROM THE FIELD AS A CLASS III RECALL.

    Description of Event or Problem · 1

    THE PT WAS BURNED BY LEAVING THE LIGHTED SECTION ON THEIR BELLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REUSABLE SUCTION DEVICE CATHETER TIP, SUCTION JOL INVUITY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other