BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEER LIGHT ECG

    MDR report key: 17534904 · Received August 12, 2023

    Report

    Report Number
    MW5141804
    Event Type
    Injury
    Date Received
    August 12, 2023
    Date of Event
    February 15, 2017
    Report Date
    March 9, 2017
    Manufacturer
    STRYKER CORP.
    Product Code
    MWJ
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS LETTER IS TO INFORM YOU OF AN EVENT THAT OCCURRED AT (B)(6) HOSPITAL OF THE (B)(6) IN (B)(6) ON (B)(6) 2017 IN WHICH IT WAS ALLEGED THAT THE SEER LIGHT ECG HOLTER MONITOR CAUSED BURN MARKS TO A PATIENT. IT WAS REPORTED THAT THE HOLTER MONITOR WAS PLACED ON A CHILD ON (B)(6) 2017 AND AGAIN ON (B)(6) 2017 AND IN BOTH INCIDENTS, THE CHILD HAD RED BURN SPOTS WHERE THE ELECTRODES WERE PLACED. THE CONTACT INFORMATION OF (B)(6) HOSPITAL OF THE (B)(6) IS AS FOLLOWS: THE SEER LIGHT IS MANUFACTURED BY THE SUZUKEN COMPANY WHICH IS IN JAPAN. THE SUZUKEN COMPANY WAS INFORMED OF THIS EVENT ON FEBRUARY 17, 2017. WHEN INFORMING SUZUKEN ABOUT THIS ADVERSE EVENT, THEY ALLEGE THAT THE BURNS ARE CAUSED BY THE ELECTRODES THAT WERE ATTACHED TO THE PATIENT SKIN. HOWEVER, THIS INFORMATION HASN'T BEEN CONFIRMED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216795 SEER LIGHT ECG ELECTROCARDIOGRAPH, AMBULATORY (WITHOUT ANALYSIS) MWJ STRYKER CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SUZUKEN COMPANY HOLTER MONITOR