BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEROMACATH

    MDR report key: 1770153 · Received July 22, 2010

    Report

    Report Number
    1770153
    Event Type
    Malfunction
    Date Received
    July 22, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 22, 2010
    Manufacturer
    GREER MEDICAL, INC
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAS A LESION ON HIS BACK WITH A SEROMA DRAIN PLACED ONE WEEK AGO TO DRAIN THE ULCERATED LESION. THE DRAIN BECAME KINKED AND WAS NOT DRAINING. A NEW SEROMA DRAIN WAS PLACED, BUT THE PLASTIC SLEEVE OF CATHETER KINKED AND TORE WHEN ADVANCED THROUGH THE SKIN. TWO DRAINS KINKED AND TORE, AND A THIRD DRAIN WAS FINALLY SECURED IN PLACE. THE DRAIN HAD TO BE SEWN IN PLACE UPSIDE DOWN TO PREVENT DAMAGE TO THE CATHETER SLEEVE. THE PATIENT WAS NOT INJURED, AND THE DRAIN WAS PATENT AND FUNCTIONING AT THE CONCLUSION OF THE PROCEDURE.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THE CATHETER WAS NOT FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEROMACATH CATHETER, DRAINAGE GCY GREER MEDICAL, INC * 102209

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR