BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIZACT

    MDR report key: 8710362 · Received June 18, 2019

    Report

    Report Number
    1717344-2019-00782
    Event Type
    Injury
    Date Received
    June 18, 2019
    Date of Event
    December 4, 2017
    Report Date
    June 18, 2019
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT SOLD IN US AND IS 510(K) EXEMPT. THIS REPORT IS ASSOCIATED TO A SIMILAR PRODUCT SOLD IN THE US WITH 510(K) NUMBER K171066. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, POST OPERATIVELY, THE PATIENT RETURNED TO THE FACILITY REFERRING ACTIVE BLEEDING. ONE DAY HOSPITALIZATION AND SURGERY WITH MONOPOLAR COAGULATION WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502945 BIZACT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER BZ4212

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R