BEUDAMED
    FDA Adverse Event Other Summary report: N

    5.0/3.7 MHZ OMNI TEE TRANSDUCER

    MDR report key: 349015 · Received August 24, 2001

    Report

    Report Number
    1218950-2001-00184
    Event Type
    Other
    Date Received
    August 24, 2001
    Report Date
    July 25, 2001
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    ITX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT HAD CHEMICAL BURNS IN THE REAR THROAT AFTER PROLONGED INSERTION OF THE TEE PROBE THAT HAD BEEN DISINFECTED WITH CIDEX OPA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38625 5.0/3.7 MHZ OMNI TEE TRANSDUCER TRANSESOPHAGEAL TRANSDUCER ITX AGILENT TECHNOLOGIES, INC. 21364A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other