BEUDAMED
    FDA Adverse Event Other Summary report: N

    NAVISTAR DS DEFLECTABLE 8MM TIP CATHETER

    MDR report key: 517711 · Received March 25, 2004

    Report

    Report Number
    2020638-2004-00009
    Event Type
    Other
    Date Received
    March 25, 2004
    Date of Event
    January 2, 2003
    Report Date
    January 15, 2003
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ONE MONTH POST PROCEDURE DURING A FOLLOW UP VISIT PATIENT DESCRIBED AN ERYTHEMATOUS AREA AT THE LEFT MID AXILLA. EXAMINATION SHOWED A RED 2CM AREA. THIS WAS TREATED WITH ANTIBIOTICS. THIS LESION MAY HAVE BEEN A BURN FROM BENEATH A CORNER OF THE INDIFFERENT ELECTRODE PAD. PATIENT PROGNOSIS IS EXCELLENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVISTAR DS DEFLECTABLE 8MM TIP CATHETER THERAPEUTIC CATHETER DQO BIOSENSE WEBSTER, INC. D-1201-0 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other STOCKERT 70 RF GENERATOR, VALLEY LAB POLYHESIVE| INDIFFERENT ELECTRODE 2003.