BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHYSICAL THERAPY ULTRASOUND

    MDR report key: 318810 · Received March 2, 2001

    Report

    Report Number
    318810
    Event Type
    Malfunction
    Date Received
    March 2, 2001
    Date of Event
    February 8, 2001
    Report Date
    February 19, 2001
    Manufacturer
    PHYSIO TECHNOLOGY INC
    Product Code
    IMG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING AN ULTRASOUND TO THE PT'S RIGHT WRIST, PT COMPLAINED OF A SHOCK FEELING TO THE AREA MEDIALLY TO SCAR THAT "PASSED AS SOON AS IT CAME". PT'S HAND WITHOUT CHANGE IN SKIN COLOR AND NEGATIVE SENSITIVITY TO TOUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9082 PHYSICAL THERAPY ULTRASOUND * IMG PHYSIO TECHNOLOGY INC 3000 US NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other TIME OF THE EVENT.| NOTHING ELSE WAS BEING USED ON THE PATIENT AT THE