BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONMED ECG BACKPAD

    MDR report key: 384467 · Received March 22, 2002

    Report

    Report Number
    1317214-2002-00022
    Event Type
    Other
    Date Received
    March 22, 2002
    Date of Event
    February 15, 2002
    Report Date
    February 25, 2002
    Manufacturer
    CONMED CORPORATION
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT "IN 2002, PATIENT HAD A BREAST BIOPSY DONE AND A BACKPAD ECG ELECTRODE WAS PLACED ON THEIR BACK. SIX DAYS LATER, THE ECG APPLICATION SITE BECAME RED AND ITCHY. IT WAS DIAGNOSED AS CONTACT DERMATITIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED ECG BACKPAD BACK PAD DRX CONMED CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other