BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3873943 · Received May 14, 2014

    Report

    Report Number
    3873943
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 7, 2014
    Report Date
    May 14, 2014
    Manufacturer
    SMITH AND NEPHEW , INC.
    Product Code
    OMP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NEGATIVE PRESSURE WOUND THERAPY MACHINE ALARM FAILURE OCCURRED. THE DRESSING WAS NOT INTACT AND THE UNIT WAS NOT ALARMING; DRAINAGE WAS VISIBLE THROUGH THE DRESSING AND LEAKING DOWN THE LEG OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287913 * WOUND VAC OMP SMITH AND NEPHEW , INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR