BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECG MONITORING ELECTRODE

    MDR report key: 8406 · Received March 4, 1994

    Report

    Report Number
    37045-1993-09002
    Event Type
    Injury
    Date Received
    March 4, 1994
    Date of Event
    December 2, 1993
    Report Date
    March 4, 1994
    Manufacturer
    MARQUETTE ELECTRONICS, INC
    Product Code
    DRX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    FEMALE WITH KNOWN ALLERGIES HAD SKIN REACTIONS TO AREAS WHERE ELECTRODES WERE PLACED. CAUSAL RELATIONSHIP OF ELECTRODES IS UNDETERMINED. USER REPORT WAS INDICATED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECG MONITORING ELECTRODE ECG ELECTRODE DRX MARQUETTE ELECTRONICS, INC 9653-005 27 FEB 95A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention