BEUDAMED
    FDA Adverse Event Other Summary report: N

    HI RES ELECTRODES

    MDR report key: 179596 · Received July 29, 1998

    Report

    Report Number
    1225215-1998-00009
    Event Type
    Other
    Date Received
    July 29, 1998
    Date of Event
    June 29, 1998
    Report Date
    July 29, 1998
    Manufacturer
    CAMBRIDGE HEART, INC.
    Product Code
    JOS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED AN ADVERSE REACTION RESULTING IN SKIN DISCOLORATION. PATIENT SKIN PREPARATIONS WAS PERFORMED AND ELECTRODES WERE PLACED. AN ALMOST IMMEDIATE BURNING SENSATION WAS NOTED. AT THE END OF THE TEST ELECTRODES WERE REMOVED AND AREAS WIPED WITH DRY CLOTH. THAT EVENING PATIENT STILL EXPERIENCED BURNING SENSATION. FOLLOWING DAY PATIENT SOUGHT ADVICE OF A DERMATOLOGIST, WHO INDICATED SITE APPEARED TO BE A GEL ALLERGY OR A BURN. DR SUPPLIED STEROID OINTMENT, WHICH WAS USED ON ALL ELECTRODE SITES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI RES ELECTRODES ECG ELECTRODES JOS CAMBRIDGE HEART, INC. * 511390

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other