BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STABLE BASE

    MDR report key: 16680267 · Received April 5, 2023

    Report

    Report Number
    8020045-2023-00008
    Event Type
    Injury
    Date Received
    April 5, 2023
    Report Date
    April 5, 2023
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    DRX
    UDI-DI
    10861779000274
    PMA / PMN Number
    K023503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINED SAMPLES OF THE CONCERNED LOT/BATCH OF MODEL: SBT601 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. THE PRODUCT DOES NOT CONTAIN ANY LATEX, WHICH WAS COMMUNICATED TO THE USER. IT IS CONCEIVABLE THAT HER PREEXISTING SKIN ISSUES HAVE CONTRIBUTED OR CAUSED THE INCIDENT. NO FURTHER ANALYSIS CAN BE PERFORMED. WE THEREFORE CONSIDER THE INVESTIGATION AND THE REPORT CLOSED.

    Description of Event or Problem · 0

    ON MARCH 09TH, 2023, WE HAVE BEEN INFORMED AN INCIDENT WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL: SBW601) HAD BEEN USED. THE INITIAL REPORT STATED "I AM TRYING TO FIND OUT MORE INFORMATION ABOUT THE ELECTRODES I WAS SUPPLIED WITH FOR A 30 DAY CARDIAC MONITOR. I HAVE ATTACHED A PICTURE WITH PRODUCT INFORMATION. DO THESE ELECTRODES CONTAIN ANY LATEX? I HAD AN ALLERGIC REACTION AND I WOULD LIKE TO IDENTIFY IF IT IS LATEX (KNOWN ALLERGEN), ADHESIVE, OR SOMETHING ELSE. THE COMPANY WHO PROVIDED ME WITH THE ELECTRODES COULD NOT ANSWER MY QUESTION." ATTACHED TO THESE INITIAL REPORT A PHOTO WAS PROVIDED SHOWING A POUCH OF STABLE BASE ECG ELECTRODE LOT NUMBER: 220715-0153. ON MARCH 13RD, 2023 WE HAVE RECEIVED ADDITIONAL INFORMATION IN A FILLED IN QUESTIONAIRE. A MONITORING OF ARRHYTHMIA WAS PERFORMED. THE PATIENT SKIN WAS DESCRIBED AS NORMAL AND THE GENERAL STATE ALSO AS NORMAL. THE MEDICAL HISTORY WAS DESCRIBED AS "PSORIASIS, ECZEMA, MULTIPLE ALLERGIES INCLUDING LATEX, ASTHAMA". 5 ECG ELECTRODE PER USE HAVE BEEN PLACED IN THE CHEST / ABDOMEN AREA. IN TOTAL THE PATIENT USED 35 ELECTRODES IN 23 DAYS. THE PATIENT DESCRIBED THAT THE PROCEDURE SHOULD LAST FOR 30 DAYS BUT WAS "SHORTENED DUE TO SKIN IRRITATION AND NO AVAILABLE SKIN TO APPLY ELECTRODES THAT WAS INTACT / NO RASH. 23 DAYS TOTAL". THE SKIN SPREPERATION WAS DESCRIBED AS CLEANED, NOT SHAVEN, NOT DISINFECTED BUT HAS BEEN DRIED AND THE RASH WAS TREATED WITH "VTAMA, HYDROCORTISONE". THE ECG ELECTRODE WERE ADHERING TO THE PATIENT SKIN AND RESIDUES HAVES "SOMETIMES - CLEANED GENTLY WITH SOAP TO REMOVE ADHESIVE" "DURING AND AFTER 30 DAY MONITOR" IN THE CHEST, ABDOMEN AREA "REDNESS, RASH-RAISED, ITCHING THEN SCABBED AREAS" HAVE BEEN DETECTED "UNDERNEATH ADHESIVE AND GEL AREAS AROUND EDGE IN MIDDLE". THE SIZE WAS DESCRIBED AS "1-2 INCH AREAS WHERE ELECTRODES TOUCHED SKIN". THE SKIN INJURY WAS TREATED BY TOPICAL MEDICATIONS. NO FURTHER DETAILS HAVE BEEN DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1348420 STABLE BASE ECG ELECTRODE DRX LEONHARD LANG GMBH W-601 220715-0153 10861779000274

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention