BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STABLE BASE

    MDR report key: 10850219 · Received November 17, 2020

    Report

    Report Number
    8020045-2020-00027
    Event Type
    Injury
    Date Received
    November 17, 2020
    Report Date
    February 3, 2021
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    DRX
    UDI-DI
    10861779000274
    PMA / PMN Number
    K023503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINED SAMPLES OF THE CONCERNED LOT/BATCH (191111-0227, 191108-0256, 191010-0229, 191015-0222, 191107-0226, 191016-0223 AND 200122-0156) OF MODEL SBW601 HAVE BEEN INSPECTED VISUALLY. MECHANICAL TESTS WERE PERFORMED ON 3 RETAINED SAMPLES. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. NO FURTHER INFORMATION ON THE PATIENT, SKIN TYPE, STATE OF SKIN, WHETHER ANY MEDICATION WAS BEING TAKEN, WHICH MIGHT HAVE A SKIN WEAKENING EFFECT AND DETAILS OF THE USE WAS PROVIDED. THE INFORMATION PROVIDED INDICATES THAT THE IFU HAS NOT BEEN FOLLOWED. THE THIRD PATIENT'S ELECTRODES STAYED ON A TOTAL OF 11 DAYS AND WERE CHANGED ONCE WITHIN THIS PERIOD. THE IFU STATES EXPLICITLY "DO NOT USE FOR MORE THAN 72 HOURS". THE USER HAS NOT BEEN FOLLOWING THE IFU. WE THEREFORE CONCLUDE THAT A USER ERROR CAUSED THE INCIDENT OF THE THIRD PATIENT A MEDICAL INTERVENTION WAS NECESSARY. WE HAVE REQUESTED FURTHER INFORMATION FOR SEVERAL TIMES BUT NONE WAS MADE AVAILABLE. THE INITIAL REPORTER STATED THAT NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE DESPITE REPEATED REQUESTS. WE HAVE NOT BEEN ABLE TO DETERMINE, WHETHER THE IFU HAS BEEN FOLLOWED IN ALL OTHER REGARDS (ELECTRODE PLACEMENT SITES) BECAUSE OF LACK OF INFORMATION FROM THE USER. WE THEREFORE CONSIDER THE INVESTIGATION CLOSED.

    Description of Event or Problem · 0

    ON OCTOBER 19TH, 2020, WE HAVE BEEN INFORMED ABOUT 11 INCIDENTS WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL SBW601) HAD BEEN USED WITH BODYGUARDIAN ONE AND BODYGUARDIAN VERITE ONE DEVICES. THE INITIAL REPORTER HAS ATTACHED FOR EACH PATIENT AN INCIDENT SUMMARY. IN TOTAL, THERE WERE 11 REPORTS COVERING A PERIOD FROM (B)(6). NO MEDICAL INTERVENTION WAS NECESSARY FOR 8 INCIDENTS. FOR 3 INCIDENTS A MEDICAL INTERVENTION WAS NEEDED TO TREAT THE INJURY BUT NO DETAILS WERE GIVEN. BEFORE APPLYING THE ECG ELECTRODES, IN TWO CASES THE SKIN OF THE PATIENTS REQUIRING INTERVENTION WERE PREPARED USING WATER AND SOAP. THE DEVELOPED REDNESS, ITCHING, PEELING SKIN, RASH, BLISTERS, BURNING SENSATION, OPEN SORES. MEDICAL INTERVENTIONS WERE NECESSARY. THE THIRD PATIENT'S SKIN WAS NOT PREPPED. THE ELECTRODES STAYED ON A TOTAL OF 11 DAYS AND WERE CHANGED ONCE WITHIN THIS PERIOD. HE DEVELOPED REDNESS, ITCHING, RASH, BLISTERS, WELT, BURNING SENSATION, PEELING SKIN, BURNT SKIN, BLEEDING SKIN, OPEN SORES. THE PATIENT PAUSED THE STUDY TO WAIT FOR THE SKIN IRRITATION TO HEAL. A MEDICAL INTERVENTION WAS NECESSARY. ALL OTHER PATIENTS WERE PREPARED WITH DIFFERENT METHODS USING WATER AND SOAP, ALCOHOL, ALCOHOL WIPES OR SALINE WIPES BEFORE APPLYING THE ECG ELECTRODES. THE PATIENTS WERE EXPERIENCING THE "REDNESS, ITCHING, RASH, BLISTERS, WELT, BURNING SENSATION ON SKIN, PEELING SKIN, BURNT SKIN, BLEEDING, OPEN SORES." NO FURTHER INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    RETAINED SAMPLES OF THE CONCERNED LOT/BATCH (191111-0227, 191108-0256, 191010-0229, 191015-0222, 191107-0226, 191016-0223 AND 200122-0156) OF MODEL SBW601 HAVE BEEN INSPECTED VISUALLY. MECHANICAL TESTS WERE PERFORMED ON 3 RETAINED SAMPLES. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. NO FURTHER INFORMATION ON THE PATIENT, SKIN TYPE, STATE OF SKIN, WHETHER ANY MEDICATION WAS BEING TAKEN, WHICH MIGHT HAVE A SKIN WEAKENING EFFECT AND DETAILS OF THE USE WAS PROVIDED. THE INFORMATION PROVIDED INDICATES THAT THE IFU HAS NOT BEEN FOLLOWED. THE THIRD PATIENT'S ELECTRODES STAYED ON A TOTAL OF 11 DAYS AND WERE CHANGED ONCE WITHIN THIS PERIOD. THE IFU STATES EXPLICITLY "DO NOT USE FOR MORE THAN 72 HOURS". THE USER HAS NOT BEEN FOLLOWING THE IFU. WE THEREFORE CONCLUDE THAT A USER ERROR CAUSED THE INCIDENT OF THE THIRD PATIENT A MEDICAL INTERVENTION WAS NECESSARY. WE HAVE REQUESTED FURTHER INFORMATION FOR SEVERAL TIMES BUT NONE WAS MADE AVAILABLE. THE INITIAL REPORTER WAS SPECIFYING "WE CONTINUE TO ENCOURAGE THE CUSTOMER TO PROVIDE THIS INFORMATION. HOWEVER WE CAN'T FORCE THEM TO DO SO. OUR CUSTOMER IS A VERY LARGE HEALTHCARE PROVIDER IN THE UNITED STATES AND THEY HAVE A GENERAL SYSTEM FOR PATIENT COMPLAINTS. THEY WILL NOT DEVELOP A SPECIAL TRACKING SYSTEM AND PROCESS FOR LEONHARD LANG." WE HAVE NOT BEEN ABLE TO DETERMINE, WHETHER THE IFU HAS BEEN FOLLOWED IN ALL OTHER REGARDS (ELECTRODE PLACEMENT SITES) BECAUSE OF LACK OF INFORMATION FROM THE USER. WE THEREFORE CONSIDER THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    ON OCTOBER 19TH, 2020, WE HAVE BEEN INFORMED ABOUT 11 INCIDENTS WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL SBW601) HAD BEEN USED WITH BODYGUARDIAN ONE AND BODYGUARDIAN VERITE ONE DEVICES. THE INITIAL REPORTER HAS ATTACHED FOR EACH PATIENT AN INCIDENT SUMMARY. IN TOTAL, THERE WERE 11 REPORTS COVERING A PERIOD FROM JULY 16 TO AUGUST 17. NO MEDICAL INTERVENTION WAS NECESSARY FOR 8 INCIDENTS. FOR 3 INCIDENTS A MEDICAL INTERVENTION WAS NEEDED TO TREAT THE INJURY BUT NO DETAILS WERE GIVEN. BEFORE APPLYING THE ECG ELECTRODES, IN TWO CASES THE SKIN OF THE PATIENTS REQUIRING INTERVENTION WERE PREPARED USING WATER AND SOAP. THE DEVELOPED REDNESS, ITCHING, PEELING SKIN, RASH, BLISTERS, BURNING SENSATION, OPEN SORES. MEDICAL INTERVENTIONS WERE NECESSARY. THE THIRD PATIENT'S SKIN WAS NOT PREPPED. THE ELECTRODES STAYED ON A TOTAL OF 11 DAYS AND WERE CHANGED ONCE WITHIN THIS PERIOD. HE DEVELOPED REDNESS, ITCHING, RASH, BLISTERS, WELT, BURNING SENSATION, PEELING SKIN, BURNT SKIN, BLEEDING SKIN, OPEN SORES. THE PATIENT PAUSED THE STUDY TO WAIT FOR THE SKIN IRRITATION TO HEAL. A MEDICAL INTERVENTION WAS NECESSARY. ALL OTHER PATIENTS WERE PREPARED WITH DIFFERENT METHODS USING WATER AND SOAP, ALCOHOL, ALCOHOL WIPES OR SALINE WIPES BEFORE APPLYING THE ECG ELECTRODES. THE PATIENTS WERE EXPERIENCING THE "REDNESS, ITCHING, RASH, BLISTERS, WELT, BURNING SENSATION ON SKIN, PEELING SKIN, BURNT SKIN, BLEEDING, OPEN SORES." NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1315279 STABLE BASE ECG ELECTRODE DRX LEONHARD LANG GMBH W-601 200122-0156 10861779000274

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention