BEUDAMED
    FDA Adverse Event Summary report: N

    GELPORT 120MM

    MDR report key: 2222835 · Received July 26, 2011

    Report

    Report Number
    2027111-2011-00074
    Date Received
    July 26, 2011
    Date of Event
    May 9, 2011
    Report Date
    July 25, 2011
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT WAS NOT REPORTED TO APPLIED MEDICAL. WE HAVE CONTACTED THE HOSPITAL AND HAVE REQUESTED THE RETURN OF THE EVENT SAMPLE FOR OUR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    INCIDENT AS REPORTED: DURING THE MIDDLE OF THE PROCEDURE, AFTER REMOVING THE "GEL" PORTION OF THE APPLIANCE, THE SURGEON NOTICED THE PLASTIC SLEEVE TORN AWAY FROM THE RING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELPORT 120MM NONE GAD APPLIED MEDICAL C8XX2NONCE 1143068

    Patients

    Seq Age Sex Outcome Treatment
    1