BEUDAMED
    FDA Adverse Event Other Summary report: N

    DERMAL TONE

    MDR report key: 352589 · Received September 13, 2001

    Report

    Report Number
    352589
    Event Type
    Other
    Date Received
    September 13, 2001
    Date of Event
    April 17, 2001
    Report Date
    July 10, 2001
    Manufacturer
    DERMAL TONE
    Product Code
    EPG
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS RECEIVING SPEECH AND SUSTAINED POSSIBLE PACEMAKER INTERFERENCE. SKILLED NURSE OBSERVED THERAPIST SIT PT IN CHAIR AT THE TABLE TO EAT THEIR BREAKFAST AND NOTED RIGHT LEG POSITIONED BEHIND THERAPIST WITH PT UNABLE TO MOVE. MADE THERAPIST AWARE AND THERAPIST STRAIGHTENED LEG. PT BECAME SIGNIFICANTLY PALE AND NONRESPONSIVE WITH EYES OPEN AND FLAT AFFECT. PT VERY DIAPHORETIC UNABLE TO OBTAIN B/P CAROTID FAINT. 911 INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41966 DERMAL TONE FACIAL EXERCISER EPG DERMAL TONE UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other