BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SRI SURGICAL BREAST PACK

    MDR report key: 720159 · Received May 24, 2006

    Report

    Report Number
    1054451-2006-00001
    Event Type
    Injury
    Date Received
    May 24, 2006
    Date of Event
    April 13, 2006
    Report Date
    May 22, 2006
    Manufacturer
    SRI SURGICAL
    Product Code
    LRP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN THE SURGEON MADE THE INITIAL INCISION, THE BOTTOM EDGE OF THE INCISION AND SOME BREAST TISSUE WERE BURNED BY THE MEGADYNE MEDICAL COATED ELECTROSIRGICAL BLADE. THE INCIDENT OCCURRED DURING A BILATERAL BREAST AUGMENTATION. THE REPORT STATES THAT THE SURGEON HAD TO CUT OFF THE EDGE ON THE INCISION AND THE BURNED BREAST TISSUE RESULTING IN AN INDENTATION AT THE INCISION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SRI SURGICAL BREAST PACK SURGICAL PROCEDURE PACK LRP SRI SURGICAL NA 11111

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention