BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SRI/SURGICAL EXPRESS, INC

    MDR report key: 565625 · Received January 6, 2005

    Report

    Report Number
    2028626-2005-00001
    Event Type
    Malfunction
    Date Received
    January 6, 2005
    Date of Event
    December 8, 2004
    Report Date
    January 4, 2005
    Manufacturer
    SRI/SURGICAL EXPRESS, INC.
    Product Code
    FYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN SDP TECHNICIAN WHO WAS WASHING INSTRUMENTS IN A BASIN OF CLEANING SOLUTION, REPORTED EXPERIENCING A STRIKE THROUGH OF FLUID INSIDE THE SLEEVES OF A LIQUIDPROOF SURGICAL GOWN. IT IS ALLEGED THAT THE CLEANING SOLUTION SOAKED THROUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SRI/SURGICAL EXPRESS, INC SURGICAL GOWN, LARGE, LIQUIDPROOF, NS FYB SRI/SURGICAL EXPRESS, INC. NA 409790

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other