BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3001981 · Received March 11, 2013

    Report

    Report Number
    2134070-2013-00058
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 18, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    NLQ
    PMA / PMN Number
    K050343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AND WAS REPORTED TO BE DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GYNECOLOGIC LAPAROSCOPY WHEN THE DEVICE WAS SLID THROUGH THE TROCAR AND THE JAWS WERE OPENED IN THE WOUND, IT WAS NOTICED THAT A WHITE PARTICULATE MATTER FELL OUT OF THE JAWS. THE "FOREIGN BODY" WAS REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY. THE DEVICE AND THE PARTICULATE MATTER WERE REPORTED TO BE DISCARDED BY THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101471 NA NLQ STERILMED, INC. ETHACE45E

    Patients

    Seq Age Sex Outcome Treatment
    1