BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIA GAURD STANDARD SUCTION SET

    MDR report key: 2446080 · Received February 6, 2012

    Report

    Report Number
    MW5024178
    Event Type
    Malfunction
    Date Received
    February 6, 2012
    Date of Event
    January 23, 2012
    Report Date
    February 6, 2012
    Manufacturer
    SURGIMARK, INC.
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT SURGERY ON (B)(6) 2012 FOR NECROTIC BOWEL WITH LEFT HEMICOLECTOMY DONE. RETURNED TO OPERATING ROOM ON (B)(6) 2012 FOR RIGHT HEMICOLECTOMY, ILEOSIGMOID OSTOMY, EXCISION OF MESH, VENTRAL HERNIA REPAIR WITH IMPLANTATION OF MESH. ON (B)(6) 2012, PT WAS NOT TOLERATING TUBE FEEDINGS WITH INCREASED RESIDUALS WHICH PROMPTED A CT SCAN WHICH REVEALED A "FOREIGN BODY WITHIN THE LEFT PARACOLIC GUTTER OF UNCERTAIN SIGNIFICANCE." PT WAS GOING TO OPERATING ROOM FOR TRAC AND PEG TUBE INSERTION AND FOREIGN BODY :VANGUARD CONDOM: OF A SUCTION APPARATUS WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIA GAURD STANDARD SUCTION SET SURGICAL YANKAUER JOL SURGIMARK, INC. SMP-2006-001SS 84256

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR