BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XLBLEU

    MDR report key: 10395103 · Received August 12, 2020

    Report

    Report Number
    8020045-2020-00016
    Event Type
    Injury
    Date Received
    August 12, 2020
    Report Date
    November 10, 2020
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    DRX
    UDI-DI
    19005531001456
    PMA / PMN Number
    K024247
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINED SAMPLES OF THE SAME LOT HAVE BEEN INSPECTED VISUALLY AND TESTED MECHANICALLY. MECHANICAL TESTS WERE PERFORMED ON 3 RETAINED SAMPLES OF THE CLAIMED LOT NUMBER. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. THE INITIAL REPORTER STATED THAT SAMPLES OF THE SAME LOT WERE AVAILABLE FROM THE USER FOR FURTHER INVESTIGATION. HOWEVER, THE CUSTOMER RETURNED ONLY SAMPLES FROM DIFFERENT LOT NUMBERS, 200131-0204 AND 200424-0206. THE SAMPLES WERE INSPECTED VISUALLY. MECHANICAL TESTS WERE PERFORMED ON 3 SAMPLES EACH RETURNED LOT NUMBER. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. COMPARING THE ADHESIVE FORCE OF THE CLAIMED ELECTRODE TYPE WITH OTHER ELECTRODE TYPES USING THE SAME ADHESIVE FOAM HAS SHOWN THAT THERE ARE NO DIFFERENCES NOTICEABLE IN THE ADHESION FORCE. FURTHERMORE WE HAVE EXAMINED THE SUPPLIER´S COCS OF THE CONCERNED FOAM. THE DOCUMENTS HAVE SHOWN THAT THE SPECIFIED ADHESION FORCE VALUES HAVE NOT CHANGED DURING THE LAST YEAR. WE HAVE REQUESTED SEVERAL TIMES FOR FURTHER INFORMATION ON THE PATIENT, THE SKIN PREPARATION, IF AND HOW THE SKIN INJURY HAD TO BE TREATED. THE INITIAL REPORTER HAS CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE. THE INCIDENT HAS BEEN REPORTED BECAUSE IT IS UNKNOWN IF AND HOW THE SKIN INJURY HAD TO BE TREATED AFTERWARDS. THE INCIDENT MIGHT NOT CONSTITUTE A REPORTABLE EVENT. AS NO FURTHER INFORMATION WAS MADE AVAILABLE DESPITE OF REPEATED REQUESTS, NO CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE INCIDENTS. WE THEREFORE CLOSE THE INVESTIGATION.

    Description of Event or Problem · 0

    ON JULY 21ST, 2020, WE HAVE BEEN INFORMED ABOUT AN INCIDENT WITH ECG ELECTRODES AT (B)(6), IN (B)(6). XLBLEU ELECTRODES MODEL FS-WA01C WERE USED. THE COMPLAINANT REPORTED "WE SEEM TO BE RECEIVING COMPLAINTS ABOUT A PARTICULAR BATCH OF ELECTRODES FROM THE CREWS SAYING THEY ARE TOO STICKY TO THE POINT THEY ARE TEARING THE PATIENTS SKIN WHEN BEING REMOVED. THE CREWS HAVE SAID THEY HAVE COMPARED THEM TO OTHER BATCHES AND THEY APPEAR TO BE MORE STICKY. " WE HAVE REQUESTED FURTHER INFORMATION ON EACH INVOLVED PATIENT, THE SKIN PREPARATION, IF AND HOW THE SKIN INJURIES HAD TO BE TREATED.

    Additional Manufacturer Narrative · 1

    RETAINED SAMPLES OF THE SAME LOT HAVE BEEN INSPECTED VISUALLY AND TESTED MECHANICALLY. MECHANICAL TESTS WERE PERFORMED ON 3 RETAINED SAMPLES OF THE CLAIMED LOT NUMBER. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. THE INITIAL REPORTER STATED THAT SAMPLES OF THE SAME LOT ARE AVAILABLE FROM THE USER FOR FURTHER INVESTIGATION. WE HAVE ASKED TO BE SENT CUSTOMER SAMPLES OF THE SAME LOT. WE HAVE REQUESTED FURTHER INFORMATION ON THE PATIENT, THE SKIN PREPARATION, IF AND HOW THE SKIN INJURY HAD TO BE TREATED AND WILL PROVIDE A FOLLOW UP REPORT UPON RECEIPT.

    Description of Event or Problem · 1

    ON (B)(6) 2020, WE HAVE BEEN INFORMED ABOUT AN INCIDENT WITH ECG ELECTRODES AT (B)(6) HEALTHCARE NHS FOUNDATION TRUST (B)(6) SERVICE, IN (B)(6). XLBLEU ELECTRODES MODEL FS-WA01C WERE USED. THE COMPLAINANT REPORTED "WE SEEM TO BE RECEIVING COMPLAINTS ABOUT A PARTICULAR BATCH OF ELECTRODES FROM THE CREWS SAYING THEY ARE TOO STICKY TO THE POINT THEY ARE TEARING THE PATIENTS SKIN WHEN BEING REMOVED. THE CREWS HAVE SAID THEY HAVE COMPARED THEM TO OTHER BATCHES AND THEY APPEAR TO BE MORE STICKY. " WE HAVE REQUESTED FURTHER INFORMATION ON EACH INVOLVED PATIENT, THE SKIN PREPARATION, IF AND HOW THE SKIN INJURIES HAD TO BE TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862140 XLBLEU ECG ELECTRODE DRX LEONHARD LANG GMBH FSVM01 200421-0204 19005531001456

    Patients

    Seq Age Sex Outcome Treatment
    1 Other