BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELPOINT ADVANCED ACCESS PLATFORM

    MDR report key: 2994290 · Received March 1, 2013

    Report

    Report Number
    MW5029240
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    February 21, 2013
    Report Date
    March 1, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A CLEAR PLASTIC SEAL WAS NOTED TO HAVE SEPARATED FROM THE TROCAR DURING A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY. THE SEAL HAD TO BE RETRIEVED FROM THE PATIENT'S ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89084 GELPOINT ADVANCED ACCESS PLATFORM GELPOINT ADVANCED ACCESS PLATFORM GCJ APPLIED MEDICAL 1177256

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention