BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURETRACE

    MDR report key: 24872913 · Received April 14, 2026

    Report

    Report Number
    1320894-2026-00101
    Event Type
    Injury
    Date Received
    April 14, 2026
    Report Date
    May 12, 2026
    Manufacturer
    CONMED UTICA
    Product Code
    DRX
    UDI-DI
    10653405004400
    PMA / PMN Number
    K091856
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. HOWEVER, THE COMPLAINT INVESTIGATION IS NOT COMPLETE AT THIS TIME. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DEVICE 1800-005, ADULT FOAM ECG SURETRACE CONDUCTIVE ADHESIVE GEL WAS BEING REMOVED FROM THE PATIENT AND ¿SKIN INJURY FROM REMOVING THE SURE TRACE ELECTRODES.¿ FURTHER ASSESSMENT HAS BEEN SENT; HOWEVER, TO DATE NO RESPONSE HAS BEEN RECEIVED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY TO THE PATIENT¿S SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316202 SURETRACE ELECTRODE, ELECTROCARDIOGRAPH DRX CONMED UTICA 202409061 10653405004400

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown