BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STABLE BASE

    MDR report key: 11479879 · Received March 15, 2021

    Report

    Report Number
    8020045-2021-00009
    Event Type
    Injury
    Date Received
    March 15, 2021
    Report Date
    March 15, 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 · 1

    RETAINED SAMPLES OF THE MODEL SBT601 LOT NUMBER: 200228-0257, 200204-0253, 200227-0256, 200225-0255, 191029-0155, 200204-0253, 200303-0258 AND MODEL SBW601 LOTNUMBER: 200220-0253, 200219-0252, 200211-0257, 200217-0251, 200219-0252, 200121-0155, 200213-0258 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 AND HAVE BEEN INFORMED BY THE INITIAL REPORTED THAT PER HIPPA REGULATIONS MUCH OF THE INFORMATION LEONHARD LANG REQUESTS CAN'T BE REPORTED. WE THEREFORE CONSIDER THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2021, WE HAVE BEEN INFORMED ABOUT 32 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 32 REPORTS COVERING A PERIOD FROM (B)(6) 2020. NO MEDICAL INTERVENTION WAS NECESSARY FOR 29 INCIDENTS. FOR 3 INCIDENTS A MEDICAL INTERVENTION WAS NEEDED TO TREAT THE INJURY BUT NO FURTHER DETAILS WERE GIVEN. BEFORE APPLYING THE ECG ELECTRODES, THE SKIN OF THE PATIENTS REQUIRING INTERVENTION WAS PREPARED USING WATER AND SOAP. THE 3 PATIENTS DEVELOPED ITCHING, BURNING SENSATION ON SKIN, BURNT SKIN, REDNESS, WELT, PEELING SKIN AND BLEEDING. ONE PATIENT REPORT PROVIDED THE INFORMATION THAT THE PATIENT PAUSED THE STUDY TO WAIT FOR THE SKIN IRRITATION TO HEAL. A MEDICAL INTERVENTION WAS NECESSARY. ALL OTHER 29 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 "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
    377744 STABLE BASE ECG ELECTRODE DRX LEONHARD LANG GMBH T-601 200228-0257 10861779000274

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention