BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEEP

    MDR report key: 1023411 · Received April 2, 2008

    Report

    Report Number
    1216677-2008-00011
    Event Type
    Injury
    Date Received
    April 2, 2008
    Date of Event
    January 10, 2008
    Report Date
    April 2, 2008
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HGI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE NURSE USED ONE HAND ON THE NEEDLE AND THE OTHER ON THE CAP. WHILE SHE INSERTED THE NEEDLE INTO THE PROTECTIVE CAP, IT SLIPPED AND WAS STUCK BY THE NEEDLE. NO DETERMINATION OF WHETHER OFFICE PROTOCOL WAS FOLLOWED IN THE HANDLING OF THE POTOCKY NEEDLE. THERE HAVE BEEN NO OTHER REPORTED ACCIDENTAL NEEDLE STICKS.

    Description of Event or Problem · 1

    IN PREPARATION OF A LEEP PROCEDURE, A NURSE WAS STUCK WITH A POTOCKY NEEDLE AFTER IT WAS USED. BLOOD WAS DRAWN FROM THE NURSE TO CHECK FOR STDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEEP POTOCKY NEEDLE HGI COOPERSURGICAL, INC. 6066

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention