BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEG SENSOR V6 LEFT OR RIGHT TP

    MDR report key: 2565393 · Received May 3, 2012

    Report

    Report Number
    MW5025310
    Event Type
    Malfunction
    Date Received
    May 3, 2012
    Date of Event
    April 15, 2012
    Report Date
    May 3, 2012
    Manufacturer
    COMPUMEDICS
    Product Code
    LEL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THREE PATIENTS RECEIVED BURNS ON LEGS AT THE SITE WHERE A LEG SENSOR WAS APPLIED DURING SLEEP STUDY TESTING. FIRST PATIENT AND SECOND PATIENT, (B)(6), NOTIFIED SLEEP CENTER OF BURNS ON (B)(6) 2012. DATE OF BURNS (B)(6) 2012. THIRD PATIENT NOTIFIED OFFICE DURING A FOLLOW UP VISIT ON (B)(6) 2012, (B)(6). THAT HE RECEIVED A BURN ON LEG WHEN IN FOR TESTING ON (B)(6) 2012. PICTURES FROM PATIENT, (B)(6), WERE FORWARDED TO SLEEP CENTER AND THERE APPEARED TO BE A RAISED BLISTER AT THE SITE OF WHERE LEG SENSORS WERE ATTACHED. NO MEDICAL TREATMENT WAS RECEIVED BY ANY OF THESE PATIENTS TO DETERMINE IF AN ALLERGIC REACTION OR CHEMICAL BURN MAY HAVE CAUSED BURN. ALSO SEE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEG SENSOR V6 LEFT OR RIGHT TP "LEG PADDLES" LEL COMPUMEDICS 7000-0100-01 ITEMS RETURNED

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other