BEUDAMED
    FDA Adverse Event Other Summary report: N

    GELPORT SYSTEM W/ALEXIS O RETRACTOR

    MDR report key: 1003067 · Received February 22, 2008

    Report

    Report Number
    2027111-2008-00002
    Event Type
    Other
    Date Received
    February 22, 2008
    Date of Event
    January 22, 2008
    Report Date
    February 22, 2008
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: THE 1 GELPORT 120MM WAS RETURNED USED. UPON VISUAL INSPECTION, THE GELCAP WAS FOUND TO HAVE NO TEARS OR HOLES IN THE GEL. FURTHER, THE GELPORT ALEXIS WOUND RETRACTOR WAS FOUND TO HAVE A TEAR ON THE SHEATH. THE TEAR WAS NOT NEAR OR ON ANY HEAT SEALED AREAS. CONCLUSION/CORRECTIVE ACTION: THE GELPORT ALEXIS WOUND RETRACTOR WAS FOUND TO HAVE A TEAR ON THE FILM. THE TEAR WAS NO WHERE NEAR OR ON ANY HEAT SEALED AREAS. IT IS UNK HOW THE DEVICE WAS INSERTED INTO THE PT OR WHAT TYPE OF INSTRUMENTATION WAS INSERTED THROUGH THE ALEXIS WOUND RETRACTOR. NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    "UPON PLACEMENT GEL RIPPED." PT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELPORT SYSTEM W/ALEXIS O RETRACTOR GELPORT SYSTEM GAD APPLIED MEDICAL RESOURCES C8XX2 1040451

    Patients

    Seq Age Sex Outcome Treatment
    1 Other