BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HET

    MDR report key: 8166793 · Received December 14, 2018

    Report

    Report Number
    1717344-2018-01631
    Event Type
    Injury
    Date Received
    December 14, 2018
    Date of Event
    November 16, 2018
    Report Date
    September 17, 2019
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    UDI-DI
    10884521511132
    PMA / PMN Number
    K140422
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, THE PROCEDURE WAS DONE ON (B)(6) 2018, AND THE PATIENT CAME TO THE EMERGENCY ROOM ON FRIDAY (B)(6) 2108, COMPLAINING OF SEVERAL RECTAL PAIN. UPON EXAMINATION, IT WAS DISCOVERED THAT THE BIPOLAR ENERGY WAS APPLIED BELOW THE DENTATE LINE AND CAUSED AN ULCER WHICH SCABBED OVER.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTION: IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE PATIENT CAME TO THE EMERGENCY ROOM AFTER HOW MANY THE PROCEDURE WAS DONE, COMPLAINING OF SEVERAL RECTAL PAIN. UPON EXAMINATION, IT WAS DISCOVERED THAT THE BIPOLAR ENERGY WAS APPLIED BELOW THE DENTATE LINE AND CAUSED AN ULCER WHICH SCABBED OVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005665 HET ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER 180-1022 10884521511132

    Patients

    Seq Age Sex Outcome Treatment
    1 Other