BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3042950 · Received April 4, 2013

    Report

    Report Number
    2134070-2013-00077
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 14, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    NLM
    PMA / PMN Number
    K111002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR AS OF THE DATE OF THIS REPORT. A F/U REPORT WILL BE SENT IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BARIATRIC SLEEVE PROCEDURE, GAS LEAKED FROM THE DEVICE. THERE WAS DIFFICULTY MAINTAINING PNEUMOPERITONEUM AND "EXCESSIVE" GAS WAS USED. THE DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PT INJURY. ADD'L INFO WAS REQUESTED, BUT NO ADD'L INFO WAS AVAILABLE, A F/U REPORT WILL BE SENT IF ADD'L INFO IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138728 NA NLM STERILMED, INC. APPC0R37

    Patients

    Seq Age Sex Outcome Treatment
    1