BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSENSE WEBSTER

    MDR report key: 10419736 · Received August 18, 2020

    Report

    Report Number
    10419736
    Event Type
    Malfunction
    Date Received
    August 18, 2020
    Date of Event
    July 2, 2020
    Report Date
    July 30, 2020
    Manufacturer
    STERILMED, INC.
    Product Code
    OWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    POOR IMAGE FROM A REPROCESSED INTRACARDIAC ECHO CATHETER. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887853 BIOSENSE WEBSTER REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER OWQ STERILMED, INC. R10438577 2115286

    Patients

    Seq Age Sex Outcome Treatment
    1 28835 DA