BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ER

    MDR report key: 3587105 · Received December 31, 2013

    Report

    Report Number
    1119903-2013-00003
    Event Type
    Injury
    Date Received
    December 31, 2013
    Date of Event
    December 11, 2013
    Report Date
    December 16, 2013
    Manufacturer
    BTE TECHNOLOGIES, INC.
    Product Code
    IKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    JOB APPLICANT PULLED A TENDON WHILE ATTEMPTING TO PERFORM AN EXERCISE WHILE IN A PHYSICAL POSITION THAT WOULD BE REQUIRED FOR THE JOB THAT THE PERSON APPLIED FOR. THE INJURY OCCURRED DURING EXERCISE THAT WAS NOT BTE-DEVICE-SPECIFIC AND COULD HAVE BEEN PERFORMED AGAINST A WALL. THE EQUIPMENT DID NOT CAUSE OR CONTRIBUTE TO THE INJURY. THE DEVICE WAS USED IN A PROPER MANNER, WAS NOT MALFUNCTIONING, AND THERE WAS NO NEED TO CONDUCT A SPECIFIC DEVICE EVALUATION.

    Description of Event or Problem · 1

    JOB APPLICANT WAS PERFORMING A CART PUSH TEST UTILIZING BTE EVALUATION EQUIPMENT. DURING THIS TEST, THE INDIVIDUAL WAS IN A STAGGERED STANCE AND ONE FOOT WAS IN A PLANTARFLEXED POSITION AND THEN WENT TO A NEUTRAL POSITION. THE INDIVIDUAL COMPLAINED OF PAIN. THE CLINICIAN WHO ADMINISTERED THE TEST WALKED THE INDIVIDUAL OVER TO THE URGENT CARE CENTER (CONNECTED TO THIS CLINIC) TO BE EXAMINED. THE CLINICIAN LEFT THE INDIVIDUAL THERE AND CONTACTED HIM THE NEXT DAY. THE JOB APPLICANT TOLD THE CLINICIAN THAT HE DID NOT GET LOOKED AT AND HIS ANKLE/FOOT WAS SORE BUT FELT BETTER. DURING FOLLOW UP, BTE PERSONNEL LEARNED THAT THE PERSON HAD AN MRI, WAS DIAGNOSED WITH A TORN ACHILLES TENDON, AND SURGERY WAS PERFORMED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682764 ER IKK-SYSTEM, ISOKINETIC TESTING & EVALUATION IKK BTE TECHNOLOGIES, INC. ER

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention