BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMOKE EVACUATION - ACE700

    MDR report key: 11769867 · Received May 4, 2021

    Report

    Report Number
    1721194-2021-00038
    Event Type
    Injury
    Date Received
    May 4, 2021
    Date of Event
    April 8, 2021
    Report Date
    April 8, 2021
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    FYD
    PMA / PMN Number
    K141587
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNKNOWN; CAPTURED AS AWARENESS DATE. THIS REPORT IS RELATED TO A CLINICAL EVALUATION REPORT FROM A RELATED RESEARCH ACTIVITY DATABASE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DRRA) FOR PATIENTS UNDERGOING UNKNOWN PROCEDURE. THE REPORTED COMPLICATION AS PER ICD 9 & 10 CATEGORIZATION EXPERIENCED BY THE FOLLOWING WITH CORRESPONDING INTERVENTION: PATIENT HAD PERI-OPERATIVE COMPLICATION AFTER THE PROCEDURE WITH THE USE OF THE DEVICE AND BEFORE THE DISCHARGE OF THE INDEX HOSPITALIZATION WERE DEFINED WITH THE DIAGNOSIS CODE, BLEEDING. PATIENT HAD PERI-OPERATIVE COMPLICATION AFTER THE PROCEDURE WITH THE USE OF THE DEVICE AND BEFORE THE DISCHARGE OF THE INDEX HOSPITALIZATION WERE DEFINED WITH THE DIAGNOSIS CODE, BLOOD TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668945 UNK_SMOKE EVACUATION - ACE700 MEGADYNE ACE 700 ZIP PEN C CONNECTOR FYD MEGADYNE MEDICAL PRODUCTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention