BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STABLE BASE

    MDR report key: 10850224 · Received November 17, 2020

    Report

    Report Number
    8020045-2020-00028
    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 (191029-0155, 191104-0157 AND 200130-0259) OF MODEL SBT601 HAVE BEEN INSPECTED VISUALLY. MECHANICAL TESTS WERE PERFORMED ON 3 RETAINED SAMPLES EACH. 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 OCTOBER 19TH, 2020, WE HAVE BEEN INFORMED ABOUT 14 INCIDENTS WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL SBT601) 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 14 REPORTS COVERING A PERIOD FROM (B)(6). NO MEDICAL INTERVENTION WAS NECESSARY FOR 13 INCIDENTS. FOR 1 INCIDENT A MEDICAL INTERVENTION WAS NEEDED TO TREAT THE INJURY BUT NO FURTHER DETAILS WERE GIVEN. BEFORE APPLYING THE ECG ELECTRODES, THE SKIN OF THE PATIENT REQUIRING INTERVENTION WAS PREPARED USING WATER AND SOAP. HE DEVELOPED OPEN SORES AND BLEEDING. THE PATIENT PAUSED THE STUDY TO WAIT FOR THE SKIN 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 (191029-0155, 191104-0157 AND 200130-0259) OF MODEL SBT601 HAVE BEEN INSPECTED VISUALLY. MECHANICAL TESTS WERE PERFORMED ON 3 RETAINED SAMPLES EACH. 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 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 (B)(6)." WE THEREFORE CONSIDER THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2020, WE HAVE BEEN INFORMED ABOUT 14 INCIDENTS WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL SBT601) HAD BEEN USED WITH BODY GUARDIAN ONE AND BODY GUARDIAN VERITE ONE DEVICES. THE INITIAL REPORTER HAS ATTACHED FOR EACH PATIENT AN INCIDENT SUMMARY. IN TOTAL, THERE WERE 14 REPORTS COVERING A PERIOD FROM JULY 02 TO AUGUST 17. NO MEDICAL INTERVENTION WAS NECESSARY FOR 13 INCIDENTS. FOR 1 INCIDENT A MEDICAL INTERVENTION WAS NEEDED TO TREAT THE INJURY BUT NO FURTHER DETAILS WERE GIVEN. BEFORE APPLYING THE ECG ELECTRODES, THE SKIN OF THE PATIENT REQUIRING INTERVENTION WAS PREPARED USING WATER AND SOAP. HE DEVELOPED OPEN SORES AND BLEEDING. THE PATIENT PAUSED THE STUDY TO WAIT FOR THE SKIN 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
    1315282 STABLE BASE ECG ELECTRODE DRX LEONHARD LANG GMBH T-601 200130-0259 10861779000274

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention