BEUDAMED
    FDA Adverse Event Other Summary report: N

    HI-RES ELECTRODE

    MDR report key: 137097 · Received December 9, 1997

    Report

    Report Number
    1225215-1997-00001
    Event Type
    Other
    Date Received
    December 9, 1997
    Date of Event
    September 16, 1997
    Report Date
    November 21, 1997
    Manufacturer
    CAMBRIDGE HEART INC.
    Product Code
    DRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CONTACT DERMATITIS AT SITE OF APPLICATION OF ELECTRODES. INITIAL PREPARATION OF SKIN UNSUCCESSFUL DUE TO SKIN CARE PRODUCT WORN BY PT. THIS PREPARATION INCLUDED SANDING THE SKIN WITH 3M SKIN PREPARATION TAPE. PT'S SKIN WAS THEN CLEANED WITH ETHANOL (CONTRA-INDICATED IN THE LABELING) AND THE SAND-PAPER PREP. REPEATED. REACTION OCCURRED WITHIN 24 HRS. ERYTHEMA AND BLISTERING NOTED. WEALS IN DISTRIBUTION OF ELECTRODES AND IN THE LINE OF APPLICATION OF THE SAND PAPER. TREATED WITH TOPICAL STEROID APPLICATION. RESOLVED WITH NO SERIOUS SEQUELAE. INVESTIGATION LEAD TO CONCLUSION THAT EVENT WAS REPORTABLE ON 11/13/97.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other