BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREFERRED MEDICAL PRODUCTS

    MDR report key: 2135174 · Received June 15, 2011

    Report

    Report Number
    MW5021030
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 15, 2011
    Manufacturer
    PREFERRED MEDICAL
    Product Code
    ITX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN INTRA OPERATIVE ULTRASOUND WAS REQUIRED TO DETERMINE CSF FLOW. A STERILE PROBE COVER WAS REMOVED FROM PACKAGING, FILLED WITH STERILE ULTRASOUND GEL, AND PLACED OVER A CLEAN ULTRASOUND PROBE AND HANDED TO THE SURGEON IN A STERILE FASHION. THE BAGGED PROBE WAS PLACED DIRECTLY IN THE SURGICAL WOUND. WHILE USING THE ULTRASOUND PROBE, THE SURGEON NOTICED THE GEL FROM THE INSIDE OF THE PROBE COVER WAS ON HIS HANDS AND IN THE SURGICAL FIELD. AFTER EXAMINING THE PROBE COVER, THERE SEEMED TO BE SEVERAL MICRO HOLES AT BOTTOM OF BAG. THE WOUND WAS IRRIGATED WITH H2O2, BETADINE AND ANTIBIOTIC SOLUTION. A BROAD BASED IV ANTIBIOTIC GIVEN IN ADDITION TO THE PREOP ANTIBIOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREFERRED MEDICAL PRODUCTS STERILE PROBE COVER - ONE POLYETHYLENE BAG 5"X72" ITX PREFERRED MEDICAL PC-0572 TF CE0482

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization