BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI RES ELECTRODE

    MDR report key: 282096 · Received June 17, 2000

    Report

    Report Number
    1225215-2000-00001
    Event Type
    Injury
    Date Received
    June 17, 2000
    Report Date
    June 13, 2000
    Manufacturer
    CAMBRIDGE HEART, INC.
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT REPORTEDLY SUFFERED FROM ANAPHYLACTIC SHOCK APPROX ONE DAY AFTER EXPOSURE TO ELECTRODES DURING STRESS TEST. PT REPEATEDLY WENT TO EMERGENCY ROOM FOR TREATMENT. AN ALLERGIC REACTION TO THE ELECTRODE GEL WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI RES ELECTRODE ECG ELECTRODE DRX CAMBRIDGE HEART, INC. * 515425

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R