BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASMUTH

    MDR report key: 1222511 · Received November 5, 2008

    Report

    Report Number
    8020045-2008-00010
    Event Type
    Injury
    Date Received
    November 5, 2008
    Report Date
    November 3, 2008
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    DRX
    PMA / PMN Number
    K024247
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION, MECHANICAL AND ELECTRICAL TESTS, ALL PERFORMED ON RETAINED AND RETURNED SAMPLES OF THE SAME LOT, SHOWED ALL ELECTRODES TO BE WELL WITHIN LIMITS. THE GEL'S PH VALUE OF THOSE SAMPLES WAS ALSO MEASURED AND FOUND TO BE WELL WITHIN LIMITS. THE MANUFACTURING REPORT OF THE GEL LOT USED FOR THE PRODUCTION OF THE CLAIMED LOT SHOWED NO IRREGULARITIES. FURTHERMORE, AN EXPLORATIVE WEAR TEST USING RETURNED SAMPLES HAS BEEN PERFORMED ON ONE VOLUNTEER FOR 24 HOURS. THE VOLUNTEER HAD NO SKIN REACTIONS. NO OTHER CUSTOMER WHO HAVE BEEN USING ELECTRODES OF THE SAME LOT HAVE REPORTED A SIMILAR INCIDENT (LARGE QUANTITY WERE SOLD TO OTHER CUSTOMERS). THE HOSPITAL RECEIVED A DIFFERENT LOT OF THE SAME ELECTRODES AND CONTINUES TO USE THESE WITHOUT ANY PROBLEMS. NO CONCLUSION CAN BE DRAWN AS TO WHAT HAS CAUSED THIS INCIDENT. BASED ON THESE RESULTS, WE CAN ONLY SPECULATE A CONTRIBUTING PARAMETER HAD BEEN PRESENT IN THIS HOSPITAL. THE NATURE OF THE INJURIES POINTS TO THE CONTACT SPRAY. AS THAT SPRAY HAD SUPPOSEDLY USED BEFORE WITHOUT PROBLEMS, IT MIGHT HAVE BEEN A NEW OPERATOR WITH DEVIATING PREPING PRACTICE. IT WAS NOT POSSIBLE TO VERIFY THIS DUE TO LACK OF DETAILS FROM THE HOSPITAL. THE INITIAL REPORT RECEIVED ON 6TH OF AUGUST DID NOT INDICATE ANY SERIOUS INJURY. ONLY ON SEPTEMBER 24TH, A COMPLETED QUESTIONNAIRE WAS RECEIVED DESCRIBING SOME WOUNDS AS BLEEDING. ALTHOUGH IN DOUBT, WHETHER THESE SKIN REACTIONS WOULD HAVE CAUSED PERMANENT DAMAGE WITHOUT INTERVENTION, WE DECIDED TO REPORT THIS INCIDENT.

    Description of Event or Problem · 1

    AT A HOSPITAL, IN A ANOTHER COUNTRY, FIVE SKINTACT W-VH01 ECG ELECTRODES AND A SCHILLER RECORDER ARE USED AS A STANDARD FOR 24 HOUR HOLTER ECG. THE SKIN IS USUALLY PREPPED WITH A GE CONTACT SPRAY SUITABLE IN PARTICULAR FOR ECG SUCTION ELECTRODES. DURING SUMMER (NO DATES WERE GIVEN) 15 FEMALE PATIENTS SHOWED SKIN REACTIONS DESCRIBED AS BLISTERS AND SOMETIMES BLEEDING AREAS UNDERNEATH THE ADHESIVE AREA OF THE ELECTRODES AFTER SUCH DIAGNOSTIC HOLTER PROCEDURES. THE REACTIONS WERE TREATED WITH WOUND CREAM ("ETWAS WUNDCREME"). THE HOSPITAL STATED THAT SKINTACT ELECTRODES AND THE GE SPRAY HAD BEEN USED BEFORE WITHOUT PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASMUTH ECG ELECTRODE DRX LEONHARD LANG GMBH W-VH01 70924-0917

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention