BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEFECTABLE DECAPOLAR CATHETER

    MDR report key: 501253 · Received December 5, 2003

    Report

    Report Number
    2020638-2003-00013
    Event Type
    Other
    Date Received
    December 5, 2003
    Date of Event
    November 3, 2003
    Report Date
    November 7, 2003
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HOSPITAL THAT WHEN THE PACKAGE WAS OPENED THE ELECTRODE FELL OFF. THERE WAS NO PT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEFECTABLE DECAPOLAR CATHETER DIAGNOSTIC CATHETER DQO BIOSENSE WEBSTER, INC. D-1079-218-S D08M5219

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other