BEUDAMED
    FDA Adverse Event Injury Summary report: N

    21363A BIPLANE TEE PROBE

    MDR report key: 40526 · Received September 25, 1996

    Report

    Report Number
    1218950-1996-00008
    Event Type
    Injury
    Date Received
    September 25, 1996
    Date of Event
    August 9, 1996
    Report Date
    September 24, 1996
    Manufacturer
    HEWLETT-PACKARD CO.
    Product Code
    IYO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TEE PROBE WAS CHECKED AFTER THE INCIDENT BY AN CO SALES REP. NO PROBLEMS WERE FOUND. MOST LIKELY, MEDICAL INTERVENTION WAS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A TEE EXAM, THE SURFACE OF THE STOMACH WAS INJURED AND THERE WAS SOME BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 21363A BIPLANE TEE PROBE TEE PROBE IYO HEWLETT-PACKARD CO. 21363A *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention