BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 2922106 · Received January 15, 2013

    Report

    Report Number
    2134070-2013-00008
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 21, 2012
    Report Date
    January 2, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    NLM
    PMA / PMN Number
    K111002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REPORTED TO BE DISCARDED BY THE COMPLAINANT AND WILL NOT BE RETURNED TO THE MFR. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE DEVICE SEAL FAILED AND LEAKED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO KNOWN INJURY OR CONSEQUENCES TO THE PT. THE DEVICE WAS REPORTED TO BE DISCARDED. ADDITIONAL INFO WAS REQUESTED, BUT NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22579 NA NLM STERILMED, INC. APPCTS02

    Patients

    Seq Age Sex Outcome Treatment
    1