BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STABLE BASE

    MDR report key: 12750310 · Received November 4, 2021

    Report

    Report Number
    8020045-2021-00021
    Event Type
    Injury
    Date Received
    November 4, 2021
    Report Date
    November 4, 2021
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    DRX
    UDI-DI
    120861779000288
    PMA / PMN Number
    K023503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINED SAMPLES OF THE MODEL SBT601 LOT NUMBERS 210319-0253, 210128-0154, 210127-0076, 201113-0257, 210322-0254 AND OF MODEL SBW601 LOT NUMBERS 201019-0074, 201027-0251, 200923-0259, 210128-0154 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 · 0

    ON OCTOBER 13TH, 2021, WE HAVE BEEN INFORMED ABOUT (B)(6) 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 (B)(6) REPORTS COVERING A PERIOD FROM (B)(6) 2021. NO MEDICAL INTERVENTION WAS NECESSARY FOR (B)(6) INCIDENTS. FOR 5 INCIDENTS A MEDICAL INTERVENTION WAS NEEDED TO TREAT THE INJURY. BEFORE APPLYING THE ECG ELECTRODES, THE SKIN OF THE PATIENTS REQUIRING INTERVENTION WAS PREPARED USING WATER AND SOAP RESPECTIVELY ONE PATIENT SALINE WIPE. THE 5 PATIENTS DEVELOPED "REDNESS, ITCHING, RASH, BLISTERS, BURNING SENSATION ON SKIN, PEELING SKIN, BURNT SKIN, WELT, BLEEDING, OPEN SORES". FOR ONE OF THESE PATIENTS THE REPORT PROVIDED THE INFORMATION THAT "PATIENT STATED THEIR SKIN WAS OOZING AND APPLIED CORTISONE PER DOCTOR'S ORDERS. PATIENT STATED THEY CHANGED THE ELECTRODES MULTIPLE TIMES DUE TO SPEAKING WITH US FOR POOR SKIN CONTACT." THIS PATIENT WAS UNDERGOING A 10 DAYS STUDY. ECG ELECTRODES WERE WORN FOR 6 DAYS AND WERE CHANGED WITHIN THIS TIME FOR 10 TIMES. FURTHER ON IT WAS REPORTED THAT NO SKIN IRRITATION EXISTED BEFORE APPLYING THE ECG ELECTRODES TO THE SKIN. FOR THE REMOVAL DETAILS IT WAS STATED "REMOVAL DETAILS: ABRUPTLY PEELED DRY". FOR THE OTHER FOUR OF THE FIVE PATIENTS THE FILLED IN FORM STATED ONLY (QUESTION: "MEDICAL INTERVENTION?): "YES. NO INFORMATION WAS PROVIDED AS THE TO THE TREATMENT RECEIVED." ALL OTHER 23 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
    1652620 STABLE BASE ECG ELECTRODE DRX LEONHARD LANG GMBH T-601 210319-0253 120861779000288

    Patients

    Seq Age Sex Outcome Treatment
    1 Other