BEUDAMED
    FDA Adverse Event Other Summary report: N

    GELPORT SYSTEM WITH ALEXIS RETRACTOR 120MM

    MDR report key: 1943567 · Received December 8, 2010

    Report

    Report Number
    2027111-2010-00116
    Event Type
    Other
    Date Received
    December 8, 2010
    Date of Event
    November 1, 2010
    Report Date
    December 8, 2010
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANTICIPATED TO RETURN FOLLOW UP WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    INCIDENT AS REPORTED: COLECTOMY - "WHEN SURGEON PUT THE LUBRICANT ON TOP AND READY TO ENTER HIS HAND, HE NOTICED THE SEAL WAS NOT ATTACHED TO PART OF CAP RIM. HE PUT THE GELPORT AWAY AND RETURNED TO OPEN BECAUSE HE WORRIED ABOUT THE SEAL SEPARATION WILL GET WORSE IF HE CONTINUES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELPORT SYSTEM WITH ALEXIS RETRACTOR 120MM GELPORT SYSTEM GAD APPLIED MEDICAL RESOURCES C8XX2 1118645

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention