BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STABLE BASE

    MDR report key: 5077974 · Received September 11, 2015

    Report

    Report Number
    8020045-2015-00056
    Event Type
    Injury
    Date Received
    September 11, 2015
    Report Date
    September 10, 2015
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    DRX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR DISTRIBUTOR RECEIVED A TOTAL OF NINE COMPLAINTS FROM THE SAME SUB-DISTRIBUTOR. THEY INFORMED US THESE HAD BEEN COLLECTED OVER A PERIOD OF TIME BUT COMPLAINED TOGETHER. WE CONSIDER FOUR OF THEM AS (POTENTIALLY) REPORTABLE AND ARE FILING SEPARATE MDRS FOR EACH ONE OF THESE. AS NO LOT NUMBER WAS PROVIDED FOR THIS INCIDENT, NO TESTS COULD BE PERFORMED ON RETAINED SAMPLES. DESPITE OF REPEATED REQUESTS FROM US THE INITIAL REPORTER WAS NOT ABLE TO SUPPLY US WITH MORE INFORMATION ON THE INVOLVED PRODUCT AND ON THE TREATMENT OF THE INJURY AFTERWARDS. NO CONCLUSION REGARDING THE CAUSE OF THE SKIN REACTION CAN BE DRAWN. IT WAS NOT POSSIBLE TO RECEIVE ANY FURTHER INFORMATION DESPITE REPEATED REQUESTS. NO CONCLUSION REGARDING THE CAUSE OF THE INCIDENT CAN BE DRAWN. WE THEREFORE CONSIDER THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    OUR DISTRIBUTOR RECEIVED A TOTAL OF NINE COMPLAINTS FROM THE SAME SUB-DISTRIBUTOR. THEY INFORMED US THESE HAD BEEN COLLECTED OVER A PERIOD OF TIME BUT COMPLAINED TOGETHER. WE CONSIDER FOUR OF THEM AS (POTENTIALLY) REPORTABLE AND ARE FILING SEPARATE MDR'S FOR EACH ONE OF THESE. AS NO LOT NUMBER WAS PROVIDED FOR THIS INCIDENT, NO TESTS COULD BE PERFORMED ON RETAINED SAMPLES. DESPITE OF REPEATED REQUESTS FROM US THE INITIAL REPORTER WAS NOT ABLE TO SUPPLY US WITH MORE INFO ON THE INVOLVED PRODUCT AND ON THE TREATMENT OF THE INJURY AFTERWARDS. NO CONCLUSION REGARDING THE CAUSE OF THE SKIN REACTION CAN BE DRAWN. WE WILL PROVIDE A FOLLOW UP REPORT WHEN WE WILL RECEIVE ADDITIONAL INFO.

    Description of Event or Problem · 1

    ON (B)(6) 2015 WE HAVE BEEN INFORMED ABOUT AN INCIDENT WITH ECG ELECTRODES. NO LOT NUMBER WAS PROVIDED. NO INFORMATION ON THE PROCEDURE WAS PROVIDED. ACCORDING TO THE REPORT FOUR OR FIVE ELECTRODES WERE USED. THE PATIENT'S SKIN TYPE WAS DESCRIBED AS SENSITIVE. THE SKIN WAS CLEANED WITH SALINE WATER, NOT SHAVEN, NOT DISINFECTED, AND DRIED. THE GENERAL STATE OF THE PATIENT WAS DESCRIBED AS DIZZY AND FAINT. THE QUESTIONAIRE'S QUESTION "DATA ON MEDICATION OF THE PATIENT THAT COULD CAUSE OF CONTRIBUTE TO SKIN REACTIONS" WAS ANSWERED WITH "YES". HOWEVER, NO FURTHER DETAILS WERE PROVIDED. . THE ELECTRODES WERE APPLIED TO THE CHEST AREA. THE PATIENT DISCOVERED PEELING SKIN AND BRUISES WHERE THE ELECTRODES HAD BEEN ("UNDERNEATH THE ADHESIVE AREA"). ON ONE LOCATION, THE SKIN WAS BLEEDING. IT IS NOT CLEAR WHETHER THE INJURY DEVELOPED WHEN THE INJURY DEVELOPED AS INCONCLUSIVE INFORMATION WAS PROVIDED ("RIGHT AWAY - ON SHE DIDN'T KNOW UNTIL SHE REMOVED" AND "A COUPLE OF DAYS AFTER (THE TREATMENT)". NO FURTHER INFORMATION ON HOW THE SKIN WAS TREATED AFTERWARDS HAVE BEEN REPORTED TO US.

    Description of Event or Problem · 1

    ON 08/11/2015, WE HAVE BEEN INFORMED ABOUT AN INCIDENT WITH ECG ELECTRODES. NO LOT NUMBER WAS PROVIDED. NO INFO ON THE PROCEDURE WAS PROVIDED. THE PT'S SKIN TYPE WAS DESCRIBED AS NORMAL SENSITIVE. THE SKIN WAS CLEANED WITH SALINE WATER, NOT SHAVEN, NOT DISINFECTED, AND DRIED. THE GENERAL STATE OF THE PT WAS DESCRIBED AS DIZZY AND FAINT. THE QUESTIONAIRE'S QUESTION "DATA ON MEDICATION OF THE PT THAT COULD CAUSE OR CONTRIBUTE TO SKIN REACTIONS" WAS ANSWERED WITH "YES". HOWEVER, NO FURTHER DETAILS WERE PROVIDED. THE ELECTRODES WERE APPLIED TO THE CHEST AREA. THE PT DISCOVERED PEELING SKIN AND BRUISES WHERE THE ELECTRODES HAD BEEN ("UNDERNEATH THE ADHESIVE AREA"). ON ONE LOCATION THE SKIN WAS BLEEDING. IT IS NOT CLEAR, WHETHER THE INJURY DEVELOPED WHEN THE INJURY DEVELOPED AS INCONCLUSIVE INFO WAS PROVIDED ("RIGHT AWAY - ON SHE DIDN'T KNOW UNTIL SHE REMOVED" AND "A COUPLE OF DAYS AFTER [THE TREATMENT]". NO FURTHER INFO ON HOW THE SKIN WAS TREATED AFTERWARDS HAVE BEEN REPORTED TO US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603139 STABLE BASE ECG ELECTRODE DRX LEONHARD LANG GMBH UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other