BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIN COM

    MDR report key: 11838 · Received March 2, 1994

    Report

    Report Number
    MW1000957
    Event Type
    Injury
    Date Received
    March 2, 1994
    Date of Event
    February 9, 1994
    Report Date
    February 14, 1994
    Manufacturer
    CHATTANOOGA GROUP, INC.
    Product Code
    IKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Description of Event or Problem · 1

    THE PT WAS EXERCISING HER HAMSTRING MUSCLES IN THE PRONE POSITION ON THE DEVICE. THE RANGE OF MOTION WAS SET VIA THE COMPUTER FROM APPROX 10-80 DEGREES FLEXION. THE PT WAS SET UP BY THE PHYSICAL THERAPIST WITHOUT INCIDENT. HOWEVER, WHILE EXERCISING, THE PT NOTICED SOMETHING FELT LOOSE. SHE CALLED A PHYSICAL THERAPIST ASSISTANT AND WHEN THE ASSISTANT FOUND THAT THE LEVER ARM HAD BECOME LOOSE, SHE TIGHTENED IT. SHE THEN RESTARTED THE PROGRAM AND THE MACHINE MALFUNCTIONED, PULLING THE PT'S LEG QUICKLY AND SHARPLY INTO HYPEREXTENSION. THE PT REPORTED THE SCREEN FLASHED TO A DIFFERENT PROGRAM. THE ASSISTANT QUICKLY STOPPED THE DEVICE AND SEVERAL THERAPISTS ASSISTED HER IN UNSTRAPPING THE PT'S LEG AND ASSISTING HER OFF THE UNIT. IT IS UNKNOWN WHETHER THE MECHANICAL STOPS, WHICH WERE NOT PUT IN, WOULD HAVE STOPPED THE LEVER ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIN COM ISOKINETIC EXERCISE AND TESTING IKK CHATTANOOGA GROUP, INC. 125E PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| O