BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYSGO

    MDR report key: 1902937 · Received November 4, 2010

    Report

    Report Number
    1902937
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 4, 2010
    Manufacturer
    SMITH & NEPHEW
    Product Code
    OMP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US

    Narratives

    Description of Event or Problem · 1

    AT DRESSING CHANGE, WOUND NURSE FOUND THE PRESSURE SUCTION SETTING ON 180 MM HG. PHYSICIAN'S ORDER WAS WRITTEN FOR 120 MM HG. THE SETTING WAS RETURNED TO 180 MM HG. THE WOUND NURSE ALSO OBSERVED A SPOT OF BLOOD ON THE SHEETS IN THE SAME OUTLINE AS THE TEGADERM DRESSING. NO ALARM HAD SOUNDED AS TO ALERT THAT LOW SUCTION OR BLOCKED CANISTER WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENASYSGO NEGATIVE PRESSURE WOUND THERAPY OMP SMITH & NEPHEW * *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR NO OTHER THERAPIES