BEUDAMED
    FDA Adverse Event Other Summary report: N

    ECCENTRON

    MDR report key: 3688136 · Received February 27, 2014

    Report

    Report Number
    1119903-2014-00001
    Event Type
    Other
    Date Received
    February 27, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 28, 2014
    Manufacturer
    BTE TECHNOLOGIES, INC.
    Product Code
    IKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT IS UNRELATED TO ANY PROBLEMS WITH BTE EQUIPMENT AND WAS CAUSED BY A LIMB LENGTHENING APPARATUS WORN BY THE PATIENT. A PIN INCLUDED IN THIS APPARATUS CAME IN CONTACT WITH BTE EQUIPMENT CAUSING A SMALL AMOUNT OF BLEEDING. THIS PROBLEM CAN OCCUR DURING NORMAL ACTIVITIES SUCH AS WALKING OR IF THE PATIENT BUMPS INTO AN OBJECT. BUMPING EXTERNAL PIN THAT CAUSE SUPERFICIAL SKIN BLEEDING.

    Description of Event or Problem · 1

    A PATIENT WITH AN EXTERNAL FIXATION APPARATUS ON THE LEG WAS DIRECTED TO EXERCISE ON BTE EQUIPMENT BY A SUPERVISING CLINICIAN. DURING THE EXERCISE, THE PATIENT REMOVED THEIR FOOT FROM THE EQUIPMENT'S PEDAL BEFORE THE EQUIPMENT WAS STOPPED. ONE OF THE APPARATUS PINS INSERTED THROUGH THE SKIN CAME IN CONTACT WITH THE EQUIPMENT PEDAL CAUSING A SMALL AMOUNT OF BLEEDING AT THE PIN'S ENTRY SITE. THE PATIENT SAW A DOCTOR WORKING AT THE SAME FACILITY WHO DETERMINED THAT THIS WAS NOT AN ABNORMAL SITUATION. X-RAYS WERE TAKEN AND THE PIN WAS REMOVED WITH NO FURTHER ISSUES REPORTED. THE CLINIC PERSONNEL STATED THAT THIS TYPE OF INJURY IS COMMON DURING LEG LENGTHENING TREATMENT AND THAT THE BLEEDING WAS NO WORSE THAN THE STRESS OF WALKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122717 ECCENTRON IKK-SYSTEM, ISOKINETIC TESTING AND EVALUATION IKK BTE TECHNOLOGIES, INC. ECCENTRON LE1

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other