BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THD REVOLUTION

    MDR report key: 5811694 · Received July 19, 2016

    Report

    Report Number
    MW5063546
    Event Type
    Injury
    Date Received
    July 19, 2016
    Date of Event
    June 20, 2016
    Report Date
    June 29, 2016
    Manufacturer
    THD AMERICA
    Product Code
    JAF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS HAVING A TRANSANAL HEMORRHOIDAL DEARTERIALIZATION USING THE THD REVOLUTION AND FOLLOWING THE SURGERY WAS NOTED TO HAVE 6 SMALL, SUPERFICIAL BURNS IN THE AREA SURROUNDING THE ANUS. THESE CORRESPONDED TO WHERE THE LIGHT FROM THE DEVICE WAS POSITIONED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458069 THD REVOLUTION THD REVOLUTION JAF THD AMERICA 700017

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention