BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT III SENSOR PLATINUM

    MDR report key: 4102579 · Received September 12, 2014

    Report

    Report Number
    3027765-2014-00001
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    July 31, 2014
    Report Date
    September 12, 2014
    Manufacturer
    LIFEWATCH SERVICES, INC.
    Product Code
    DSI
    PMA / PMN Number
    K110499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ELECTRODES PATIENT USED HAD NICKEL AS A COMPONENT. THE PATIENT IS ALLERGIC TO NICKEL. BELOW IS THE PRODUCT INFO FOR THE ELECTRODE USED BY THE PATIENT: NAME: CLEARTRACE ELECTRODE, SUPPLIER: CONMED, SUPPLIER PART NUMBER (B)(4).

    Description of Event or Problem · 1

    PATIENT STATED THAT SHE HAS TERRIBLE ALLERGY TO NICKEL AND HAD REQUESTED LIFEWATCH TO SEND SENSITIVE ELECTRODES. ACCORDING TO LIFEWATCH RECORDED PHONE RECORDS FROM (B)(6) 2014, DURING THE DEVICE SHIPMENT TO THE PATIENT, IT WAS NOT INDICATED THAT SHE WAS ALLERGIC TO ANYTHING. LIFEWATCH MAILED HER THE UNIT AND SHE ASSUMED THAT THE ELECTRODES SENT WERE SENSITIVE AND NON-NICKEL. SHE WORE THE MONITOR AND HAD A TERRIBLE REACTION, WHICH CAUSED HER TO HAVE BLISTERS AND SWOLLEN THROAT. PATIENT MENTIONED SHE PASSED OUT AN D COULD HAVE DID IF IT WAS NOT FOR HER HUSBAND BEING A PARAMEDIC. FURTHER, SHE STATED THAT AFTER SHE GOT DISCHARGED FROM THE HOSP SHE CALLED LIFEWATCH TO GET DETAILS AND HAD A TERRIBLE EXPERIENCE WITH THE CUSTOMER SERVICE. ACCORDING TO HER, A SUPERVISOR HAD CALLED HER BACK AND TOLD HER LIFEWATCH HAD NO DATA AND BLAMED HER FOR NOT KNOWING THE ELECTRODES HAD NICKEL. HOWEVER, LIFEWATCH RECORDED THE PHONE RECORD DOES NOT VERIFY PATIENT'S STATEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565042 ACT III SENSOR PLATINUM DETECTOR AND ALARM, ARRHYTHMIA DSI LIFEWATCH SERVICES, INC. DEV060 K2025799

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization