BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STABLE BASE

    MDR report key: 10903606 · Received November 25, 2020

    Report

    Report Number
    8020045-2020-00030
    Event Type
    Injury
    Date Received
    November 25, 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 CONCERENED LOTS (191106-0225, 191015-0222, 191029-0155, 200121-0155, 200124-0157 AND 200131-0251) OF MODEL SBT601 AND 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 INFORMATION ON THE PATIENT, SKIN TYPE, STATE OF SKIN, WHETHER ANY MEDICATION WAS BEING TAKEN, WHICH MIGHT HAVE A SKIN WEAKENING EFFECT, DURATION OF USE AND DETAILS OF THE USE WAS PROVIDED. WE HAVE REQUESTED FURTHER INFORMATION SEVERAL TIMES BUT NONE WAS MADE AVAILABLE. THE INITIAL REPORTER STATED THAT NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE DESPITE REPEATED REQUESTS. WE THEREFORE CONSIDER THE INVESTIGATION CLOSED.

    Description of Event or Problem · 0

    ON (B)(6) 2020, WE HAVE BEEN INFORMED ABOUT 10 INCIDENTS WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL SBT601 AND 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 10 REPORTS COVERING A PERIOD FROM (B)(6). ALL 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 MEDICAL INTERVENTION WAS NECESSARY FOR ANY OF THESE 10 INCIDENTS. NO FURTHER INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    RETAINED SAMPLES OF THE CONCERNED LOTS (191106-0225, 191015-0222, 191029-0155, 200121-0155, 200124-0157 AND 200131-0251) OF MODEL SBT601 AND 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 INFORMATION ON THE PATIENT, SKIN TYPE, STATE OF SKIN, WHETHER ANY MEDICATION WAS BEING TAKEN, WHICH MIGHT HAVE A SKIN WEAKENING EFFECT, DURATION OF USE AND DETAILS OF THE USE WAS PROVIDED. WE HAVE REQUESTED FURTHER INFORMATION SEVERAL TIMES BUT NONE WAS MADE AVAILABLE. THE INITIAL REPORTER STATED "WE CONTINUE TO ENCOURAGE THE CUSTOMER TO PROVIDE THIS INFORMATION. HOWEVER WE CAN'T FORCE THEM TO DO SO." AND IN A LATER COMMUNICATION "WE HAVE SPENT YEARS TRYING TO GET THIS PROVIDER TO ADD ADDITIONAL QUESTIONS TO THEIR PATIENT COMPLAIN PROCESS (FORMS) WITH NO LUCK. I'M NOT SURE THERE IS MUCH MORE I CAN DO AT THIS TIME." WE THEREFORE CONSIDER THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    ON NOVEMBER 11TH, 2020, WE HAVE BEEN INFORMED ABOUT 10 INCIDENTS WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL SBT601 AND 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 10 REPORTS COVERING A PERIOD FROM AUGUST 19 TO SEPTEMBER 28. ALL 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 MEDICAL INTERVENTION WAS NECESSARY FOR ANY OF THESE 10 INCIDENTS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1368085 STABLE BASE ECG ELECTRODE DRX LEONHARD LANG GMBH T-601 200131-0251 10861779000274

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention