BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TD 100 PROBE DISINFECTOR

    MDR report key: 5385066 · Received January 22, 2016

    Report

    Report Number
    5385066
    Event Type
    Malfunction
    Date Received
    January 22, 2016
    Date of Event
    October 29, 2015
    Report Date
    November 24, 2015
    Manufacturer
    CS MEDICAL LLC
    Product Code
    FEB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE TD-100 PROBE DISINFECTOR HAD A SMALL LEAK AND NEUTRALIZED GLUTARALDEHYDE FROM THE MACHINE GOT ON THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44981 TD 100 PROBE DISINFECTOR TRANSDUCER, ULTRASONIC, DIAGNOSTIC FEB CS MEDICAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1