BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIZACT

    MDR report key: 12273585 · Received August 4, 2021

    Report

    Report Number
    1717344-2021-01093
    Event Type
    Injury
    Date Received
    August 4, 2021
    Date of Event
    May 7, 2021
    Report Date
    August 4, 2021
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    UDI-DI
    10884521552456
    PMA / PMN Number
    K160539
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: HEALTH RELATED QUALITY OF LIFE T-14 OUTCOMES FOR PEDIATRIC BIZACT TONSILLECTOMY SOURCE: MEDICINA 2021, 57, 480 PP.1-8. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED BETWEEN JULY 2016 AND OCTOBER 2019, A STUDY EVALUATED PEDIATRIC PATIENTS (AGE 1-16) WHO UNDERWENT TONSILLECTOMY USING BIZACT. THERE WERE 146 PATIENTS AND COMPLICATIONS INCLUDED: POST-TONSILLECTOMY HEMORRHAGE AND INFECTION. THREE PATIENTS REQUIRED REOPERATION FOR BLEEDING AND HOSPITAL ADMISSION WAS REQUIRED FOR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173749 BIZACT ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER BZ4112- 10884521552456

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention