BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XLBLEU

    MDR report key: 8611711 · Received May 15, 2019

    Report

    Report Number
    8020045-2019-00011
    Event Type
    Injury
    Date Received
    May 15, 2019
    Report Date
    May 28, 2019
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    DRX
    UDI-DI
    19005531001422
    PMA / PMN Number
    K024247
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER HAS NAMED TWO LOT NUMBERS, 180823-0241 AND 180618-0245, AND HAS RETURNED A POUCH EACH FOR FUTHER INVESTIGATION. RETAINED AND RETURNED CUSTOMER SAMPLES OF BOTH LOT NUMBERS HAVE BEEN INSPECTED VISUALLY AND TESTED MECHANICALLY. MECHANICAL TESTS WERE PERFORMED ON 4 SAMPLES OF THE RETAINED AND RETURNED CUSTOMER SAMPLES OF EACH LOT NUMBER. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. WE HAVE ADDTIONALLY PERFORMED A SKIN WEAR TEST ON 3 PROBANDS FOR EACH LOT NUMBER WITH RETAINED AND RETURNED CUSTOMER SAMPLES FOR 6 HOURS. NO FAILURE WAS DETECTED WHEN WEARING THE ELECTRODES ON ALL PROBANDS. THE TWO CONCERNED LOTS HAVE IN TOTAL OF 57,600 ELECTRODES, WHICH HAVE ALL BEEN DISTRIBUTED. NO FURTHER INCIDENTS HAVE BEEN REPORTED REGARDING THESE TWO LOT NUMBERS. NO CONCLUSION REGARDING THE CAUSE OF THE SKIN REACTION CAN BE DRAWN.

    Description of Event or Problem · 0

    ON (B)(6)2019 , WE HAVE BEEN INFORMED ABOUT INCIDENTS WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL TVO01) AND UNKNOWN HEART MONITORING RECORDERS HAD BEEN USED. THE INITIAL REPORTER STATED "DEPARTMENT HAVE BEEN USING XL-TVO01 FOR OVER 12 MONTHS, STAFF HAVE RECEIVED COMPLAINTS FROM PATIENTS SAYING THE ELECTRODES ARE CAUSING 'SKIN REACTIONS' (ONE PATIENT HAD TO HAVE STEROID CREAM THE REACTION WAS SO BAD) THE ANALYSIS/READINGS FROM THE TAPES HAVE BEEN FINE THE ISSUE IS WITH THE ADHESION ON THE MICROPORE". WE HAVE RECEIVED A PARTIALLY FILLED IN QUESTIONNAIRE. A 24 HOUR MONITORING WAS PERFORMED. THE PATIENT WAS DESCRIBED AS OF SLIM BODY TYPE. NO INFORMATION WAS PROVIDED ON THE SKIN TYPE. THE SKIN WAS CLEANED WITH "STERET WIPE, FOLLOWED BY DRYING WITH A PAPER TOWEL", 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. 3 ECG ELECTRODES WERE APPLIED IN TOTAL TO THE PATIENT'S CHEST. THE DURATION OF MONITORING LASTED FOR ABOUT 24 HOURS. THE ELECTRODES ADHERED PROPERLY. "THE MORNING WHEN THE ELECTRODES WERE REMOVED", REDNESS / SKIN IRRITATION WERE DETECTED "UNDERNEATH THE GEL AND ADHESIVE AREA". THE SIZE OF THE INJURY WAS DESCRIBED AS 6CM X 6.5CM. THE INJURIES WERE TREATED BY STEROID CREAM.

    Additional Manufacturer Narrative · 1

    THE USER HAS NAMED TWO LOT NUMBERS, 180823-0241 AND 180618-0245, AND HAS RETURNED A POUCH EACH FOR FURTHER INVESTIGATION. RETAINED AND RETURNED CUSTOMER SAMPLES OF BOTH LOT NUMBERS HAVE BEEN INSPECTED VISUALLY AND TESTED MECHANICALLY. MECHANICAL TESTS WERE PERFORMED ON 4 SAMPLES OF THE RETAINED AND RETURNED CUSTOMER SAMPLES OF EACH LOT NUMBER. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. WE HAVE ADDITIONALLY PERFORMED A SKIN WEAR TEST ON 3 PROBANDS FOR EACH LOT NUMBER WITH RETAINED AND RETURNED CUSTOMER SAMPLES FOR 6 HOURS. NO FAILURE WAS DETECTED WHEN WEARING THE ELECTRODES ON ALL PROBANDS. NO CONCLUSION REGARDING THE CAUSE OF THE SKIN INJURY CAN BE DRAWN SO FAR. WE HAVE REQUESTED FURTHER INFORMATION (SKIN PREPARATION, DURATION OF WEARING, TREATMENT OF THE SKIN REACTION) AND WILL PROVIDE A FOLLOW UP REPORT UPON RECEIPT.

    Description of Event or Problem · 1

    ON APRIL 15TH, 2019, WE HAVE BEEN INFORMED ABOUT INCIDENTS WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL TVO01) AND UNKNOWN HEART MONITORING RECORDERS HAD BEEN USED. THE INITIAL REPORTER STATED "DEPARTMENT HAVE BEEN USING XL-TVO01 FOR OVER 12 MONTHS, STAFF HAVE RECEIVED COMPLAINTS FROM PATIENTS SAYING THE ELECTRODES ARE CAUSING 'SKIN REACTIONS' (ONE PATIENT HAD TO HAVE STEROID CREAM THE REACTION WAS SO BAD) THE ANALYSIS/READINGS FROM THE TAPES HAVE BEEN FINE THE ISSUE IS WITH THE ADHESION ON THE MICROPORE". WE ARE REQUESTING FURTHER INFORMATION ON THE PATIENT, THE SKIN PREPARATION, THE PROCEDURE, THE WEARING DURATION AND HOW THE INJURIES HAD TO BE TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406896 XLBLEU ECG ELECTRODE DRX LEONHARD LANG GMBH TVO01 180823-0241 19005531001422

    Patients

    Seq Age Sex Outcome Treatment
    1 Other