BEUDAMED
    FDA Adverse Event Other Summary report: N

    GELPOINT ADVANCED ACCESS PLATFORM REF: CNGL2

    MDR report key: 17583662 · Received August 21, 2023

    Report

    Report Number
    17583662
    Event Type
    Other
    Date Received
    August 21, 2023
    Date of Event
    June 13, 2023
    Report Date
    June 20, 2023
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GCJ
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING SURGICAL PROCEDURE USING GELPOINT, PIECES OF THE GELPOINT CAME OFF INSIDE THE PATIENT. TWO PIECES WERE IDENTIFIED ONE BEING A SMALL CLEAR PLASTIC AND ONE BEING A BLACK PIECE OF PLASTIC. BOTH WERE ABLE TO BE REMOVED AND ACCOUNTED FOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483402 GELPOINT ADVANCED ACCESS PLATFORM REF: CNGL2 LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CORP. CNGL2 1474873

    Patients

    Seq Age Sex Outcome Treatment
    1 13870 DA Unknown