BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2060092 · Received April 7, 2011

    Report

    Report Number
    2060092
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 7, 2011
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US

    Narratives

    Description of Event or Problem · 1

    DURING POST-OP VISIT TO THE SURGEON'S OFFICE TO REMOVE SURGICAL SITE DRAIN, THE SURGEON NOTED THAT FLUID AND AIR WERE FLOWING FROM THE EVACUATOR BULB BACK UP THE TUBING AND INTO THE WOUND. UPON FURTHER INSPECTION, THE SURGEON FOUND THE BACK-FLOW VALVE FLOATING FREELY IN THE EVACUATOR BULB. (NOTE: THE SURGICAL DRAIN IS A ROUTINE PART OF THE SURGERY.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SILICONE EVACUATOR 100CC GCY MEDLINE INDUSTRIES, INC. * P1008203 OR 010111AZC01

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR