BEUDAMED
    FDA Adverse Event Summary report: N

    COMMANDER POWERTRACK II

    MDR report key: 1702162 · Received May 20, 2010

    Report

    Report Number
    1702162
    Date Received
    May 20, 2010
    Date of Event
    May 18, 2010
    Report Date
    May 20, 2010
    Manufacturer
    JTECH MEDICAL
    Product Code
    HRW
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER PERFORMING HAND HELD DYNAMOMETRY WITH THE PATIENT, A RASH WAS NOTED IN THE LOCATION OF PRESSURE IN ALL AREAS WHERE THE DYNAMOMETER WAS PLACED ON THE PATIENT'S SKIN. THE RASH REMAINED APPROXIMATELY ONE HOUR. THE MD WAS NOTIFIED. THE PATIENT WAS SUPPOSED TO BE RE-TESTED TWO WEEKS AFTER THE PROCEDURE, BUT THIS HAS BEEN CANCELED. CONTACTED THE MANUFACTURER OF THE DYNAMOMETER AND WAS TOLD THAT THERE IS NO LATEX IN THE HEAD OF THE DEVICE.====================== HEALTH PROFESSIONAL'S IMPRESSION======================UNKNOWN====================== MANUFACTURER RESPONSE FOR MUSCLE DYNAMOMETER, COMMANDER II POWER TRACK.======================SAID NO LATEX IN HEAD THAT TOUCHES PATIENT'S SKIN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMMANDER POWERTRACK II MUSCLE DYNAMOMETER HRW JTECH MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR