BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTIVATOR FTR 2000

    MDR report key: 170983 · Received May 13, 1998

    Report

    Report Number
    MW1013910
    Event Type
    Injury
    Date Received
    May 13, 1998
    Date of Event
    March 1, 1996
    Manufacturer
    HOGAN & HARTSON
    Product Code
    IKK
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 3-25-96 PT WAS ON MOTIVATOR FIRST TIME AND "TOLD TO USE ON 50% OF MY STRENGTH, I DID SO, BUT WAS SO SORE FOR DAYS...EVEN HURT TO BREATHE." RPTR ADVISED THERAPIST OF THIS AND TOLD HER "AT MY AGE (61) I DIDN'T THINK I SHOULD BE USING THIS MACHINE AS I DIDN'T "PUMP IRON"-TREADMILL WAS MY ONLY PLANNED EXERCISE-MY "BIGGY". DUE TO MY COMPLAINT OF SEVERE PAIN & SORENESS MY VISITS ON MARCH 27, 29, AND APRIL 1, 3, & 5 WITH PROSPECTS TO BEGIN MOTIVATOR ON NEXT VISIT". MOTIVATOR WAS THEN USED ON APRIL 1, 3, 5, 8, 10. REVIEW PHYSICAL THERAPY RECORDS 3-25 THROUGH 4-19. WAS TOO SORE & IN TOO MUCH PAIN TO KEEP ADD'L APPOINTMENTS. NEVER RETURNED TO THIS PHYSICAL THERAPY UNIT. VISITED CHIROPRACTOR ON APRIL 24, 25, 26, 30, MAY 2, 7, & 10 FOR WET HEAT APPLICATIONS, ULTRA SOUND, MASSAGE, ETC. VISITED ORTHOPEDIC SURGEON (ONE WHO DID ROTATOR CUFF SURGICAL REPAIR OF RIGHT SHOULDER ON 1-23-96). SEE ALSO HIS NOTES OF 3-26, AND 4-30 WHICH REFLECT USE OF MOTIVATOR AND INJECTION IN LEFT SHOULDER. VISITS CANCELLED ON APR 23 & APRIL 30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOTIVATOR FTR 2000 THERAPEUTIC REHABILITATION EXERCISE MACHINE IKK HOGAN & HARTSON MOTIVATOR FTR 2000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Disability