BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HET

    MDR report key: 7779107 · Received August 13, 2018

    Report

    Report Number
    1717344-2018-01078
    Event Type
    Malfunction
    Date Received
    August 13, 2018
    Date of Event
    July 26, 2018
    Report Date
    September 20, 2018
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    UDI-DI
    10884521511132
    PMA / PMN Number
    K140422
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, TWO DAYS POST HEMORRHOID ENERGY THERAPY, THE PATIENT DEVELOPED A RECTOCELE (POSTERIOR VAGINAL PROLAPSE) AND RECTAL PROLAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619887 HET ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER 180-1022 10884521511132

    Patients

    Seq Age Sex Outcome Treatment
    1 Other