BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENASYSGO

    MDR report key: 1902935 · Received November 4, 2010

    Report

    Report Number
    1902935
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 4, 2010
    Manufacturer
    SMITH & NEPHEW
    Product Code
    OMP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US

    Narratives

    Description of Event or Problem · 1

    AT APPROXIMATELY 10PM, NPWT ALARM SOUNDED, AT WHICH TIME DRESSINGS REINFORCED. SHORTLY, THEREAFTER ALARM SOUNDED AGAIN AND DRESSING WAS REINFORCED WITH TRANSPARENT FILM. AT THIS TIME, CANISTER 3/4 FULL AND DRAINAGE MOVING THROUGH TUBING TO CANISTER. AT APPROXIMATELY 12 MIDNIGHT, NPWT ALARM SOUNDED AGAIN AT WHICH TIME CANISTER WAS FULL. A LARGE AMOUNT OF BRIGHT RED GELATINOUS BLOOD HAD LEAKED PAST DRESSINGS AND PULLED ON OUTSIDE OF BUTTOCKS DOWN TO KNEES. NPWT WAS DISCONTINUED AT THIS TIME. PHYSICIAN REMOVED DRESSING AND PERFORMED EVACUATION OF WOUND AT WHICH TIME A LARGE AMOUNT OF BLOOD CLOTS WERE REMOVED FROM WOUND. PHYSICIAN FOUND NO ACTIVE BLEEDING IN WOUND. THE SURGEON WHO PLACED THERAPY STATED THAT IT "APPEARED" THAT THE PUMP HAD LOST SUCTION AT SOME POINT IN TIME ALLOWING THE DRESSINGS PLACED IN THE OR THAT WERE ADHERING TO THE WOUND TO PULL AWAY AND ALLOW CLOTS TO FORM IN THE WOUND BED.

    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 62 YR Hospitalization| R NO OTHER THERAPIES