BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKINTACT

    MDR report key: 8263905 · Received January 21, 2019

    Report

    Report Number
    8020045-2019-00001
    Event Type
    Injury
    Date Received
    January 21, 2019
    Date of Event
    November 26, 2018
    Report Date
    January 21, 2019
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    DRX
    UDI-DI
    19005531001071
    PMA / PMN Number
    K023503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER HAS PROVIDED A CHOICE OF TWO LOT NUMBERS: 170905-0812 AND 180625-0186 FOR FURTHER INVESTIGATION (IT IS NOT CLEAR, WHICH LOT WAS ACTUALLY INVOLVED IN THE INCIDENT). THEREFORE, RETAINED AND RETURNED CUSTOMER SAMPLES OF BOTH LOT NUMBERS HAVE BEEN INSPECTED VISUALLY AND ELECTRICALLY. MECHANICAL TESTS WERE PERFORMED ON 4 SAMPLES OF THE RETAINED AND THE RETURNED CUSTOMER SAMPLES. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. THE TWO CONCERNED LOT NUMBERS HAVE IN TOTAL A PRODUCTION AMOUNT OF (B)(4) ELECTRODES. THESE ELECTRODES HAVE BEEN SOLD TO 6 MAJOR CUSTOMERS. NO FURTHER INCIDENTS HAVE BEEN REPORTED REGARDING THESE LOT NUMBERS. NO CONCLUSION REGARDING THE CAUSE OF THE SKIN REACTION CAN BE DRAWN.

    Description of Event or Problem · 1

    ON (B)(6) 2018, WE HAVE BEEN INFORMED ABOUT AN INCIDENT WITH ECG ELECTRODES (MODEL F-601C, TWO POTENTIAL LOT NUMBERS WERE PROVIDED) AT GALWAY CLINIC IN IRELAND. MONITORING ECG ELECTRODES (MODEL F601C) AND AN GE MONITORING SYSTEM HAD BEEN USED. WE HAVE RECEIVED A COMPLETED QUESTIONAIRE. A PULMONARY VEIN ISOLATION PROCEDURE WAS PERFORMED. THE PATIENT WAS DESCRIBED AS OF NORMAL BODY TYPE AND NORMAL SKIN. HIS GENERAL STATE WAS DESCRIBED AS NORMAL. NO CLEANING OF THE SKIN, NO SHAVING, NO DISINFECTANT OR OINTMENT HAD BEEN USED FOR PREPARING THE SKIN. NO INJURY OR SKIN LESION WAS PRESENT BEFORE APPLYING THE ECG ELECTRODES. 12 ECG ELECTRODES WERE APPLIED IN TOTAL TO THE PATIENT'S CHEST. THE DURATION OF MONITORING LASTED FOR ABOUT 3-4 HOURS. THE ELECTRODES ADHERED PROPERLY. AFTER THE TREATMENT, REDNESS AND BLISTERS WERE DETECTED UNDERNEATH THE ADHESIVE FOAM AREA OF "2-3 ELECTRODES". THE INJURIES WERE PHARMACOLOGICALLY TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56261 SKINTACT ECG ELECTRODE DRX LEONHARD LANG GMBH F-601C 180625-0186 19005531001071

    Patients

    Seq Age Sex Outcome Treatment
    1 Other