BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTRAK SMART

    MDR report key: 2352330 · Received November 25, 2011

    Report

    Report Number
    MW5023222
    Event Type
    Injury
    Date Received
    November 25, 2011
    Date of Event
    November 10, 2011
    Report Date
    November 25, 2011
    Manufacturer
    UNIVERSAL MEDICAL, INC
    Product Code
    DRT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER STATED SHE SPOKE TO MANUFACTURER AND INFORMED THEM THAT SHE HAD RECEIVED AN ELECTRICAL BURN FROM HER HEARTRAK SMART LEAD. THE MANUFACTURER TOLD HER THAT SHE HAD AN ALLERGIC REACTION. THE REPORTER SAID SHE WENT TO HER DOCTOR WHO SAID THAT SHE HAD A BURN THAT WAS HEALING FINE. REPORTER ALSO MENTIONED DISCOLORIZATION ON THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTRAK SMART HEARTRAK SMART HEART MONITOR DRT UNIVERSAL MEDICAL, INC HTSM-5

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR