BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KII SLEEVE

    MDR report key: 20037493 · Received August 21, 2024

    Report

    Report Number
    MW5158702
    Event Type
    Injury
    Date Received
    August 21, 2024
    Date of Event
    July 5, 2024
    Report Date
    August 16, 2024
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    A #12 TROCAR SLEEVE SEPARATED WHILE INTRODUCING MESH DURING A SURGICAL PROCEDURE LEAVING A SMALL BLACK RUBBER PIECE FREE IN THE PATIENT. NOTICED BY OPERATING PHYSICIANS AND RECOVERED FROM PATIENT. DEVICE AND PACKAGING WERE SAVED AND GIVEN TO MC NURSE MANAGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230898 KII SLEEVE LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CORP. 1497037

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention