BEUDAMED
    FDA Adverse Event Other Summary report: N

    TOTAL GYM

    MDR report key: 12311 · Received March 28, 1994

    Report

    Report Number
    MW1001236
    Event Type
    Other
    Date Received
    March 28, 1994
    Date of Event
    February 9, 1994
    Report Date
    February 24, 1994
    Manufacturer
    ENGINEERING FITNESS INTL. MEDICAL SYSTEMS
    Product Code
    ION
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Description of Event or Problem · 1

    PT WAS TRANSFERRING FROM DEVICE WHEN THE SLIDE BOARD ON WHICH HE WAS SITTING SUDDENLY GAVE WAY CAUSING THE PT TO BEND HIS KNEE BEYOND HIS COMFORTABLE RANGE OF MOTION. THE PT WAS 8 WKS STATUS POST TOTAL KNEE SURGERY AT THE DATE OF THE INCIDENT. X-RAYS AND MD ASSESSMENT WERE IMMEDIATELY ACCOMPLISHED WITH NO DETERMINED ADVERSE EFFECTS OTHER THAN ACUTE PAIN, MODERATE EFFUSION AND MINOR REHAB SETBACKS. THE ROOT PROBLEM HAS BEEN DETERMINED AS THE PLACEMENT OF THE CLIP WHICH HOLDS THE SLIDE BOARD STABLE. THIS COULD HAVE BEEN A FACTORY MISTAKE OR AN ASSEMBLY ERROR MADE ON SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL GYM EXERCISE ION ENGINEERING FITNESS INTL. MEDICAL SYSTEMS 42004

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other