BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ER

    MDR report key: 12139139 · Received July 8, 2021

    Report

    Report Number
    1119903-2021-00001
    Event Type
    Injury
    Date Received
    July 8, 2021
    Date of Event
    June 9, 2021
    Report Date
    June 9, 2021
    Manufacturer
    BTE TECHNOLOGIES
    Product Code
    IKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EQUIPMENT DID NOT CAUSE NOR CONTRIBUTE TO THE INCIDENT THAT OCCURRED DURING POST OFFER EMPLOYMENT TESTING (POET). POET PROTOCOL SIMULATES JOB TASKS THAT CANDIDATES WOULD BE REQUIRED TO PERFORM TO DETERMINE THEIR CAPABILITY TO PERFORM THE JOB. JOB CANDIDATES GIVE THEIR MAXIMUM EFFORT TO QUALIFY FOR THE JOB, AND MAY EXTEND THEMSELVES BEYOND THEIR PHYSICAL CAPABILITY. CANDIDATES ARE IN FULL CONTROL OF THE EXERCISE. THE DEVICE IS PASSIVE DURING THE TESTING; THERE ARE NO MOTORS OR ACTUATORS. THE INJURY OCCURRED DURING EXERCISE THAT WAS NOT BTE-DEVICE SPECIFIC AND COULD HAVE BEEN PERFORMED AGAINST A WALL. DURING A PUSH TEST, THE CANDIDATE WAS IN PROPER POSITION (IN A STAGGERED STANCE). WHILE PUSHING, HE INJURED HIS ACHILLES TENDON IN THE FORWARD FOOT DURING THE EXERCISE. THE DEVICE DID NOT MALFUNCTION, AND THERE IS NO EVIDENCE IT WAS USED INCORRECTLY. THERE IS NO NEED TO CONDUCT THE SPECIFIC DEVICE EVALUATION. ROOT CAUSES: THE CANDIDATE INJURED HIMSELF WHILE PUSHING AGAINST THE DEVICE. THE INJURY WAS CAUSED BY THE EXTENSION OF BODY PARTS DURING AN EXERCISE INTENDED TO DUPLICATE THE REQUIREMENTS OF THE JOB THE CANDIDATE APPLIED FOR. THE ROOT CAUSE WAS THE EXERCISE ITSELF AND THE PHYSICAL CAPABILITY OF THE CANDIDATE WHO WAS PERFORMING THE PUSHING EXERCISE. THE BTE PRODUCT, ALTHOUGH INVOLVED IN THE INCIDENT, WAS NOT THE DIRECT OR INDIRECT CAUSE OF THE INJURY, AS THE INJURY WOULD HAVE OCCURRED EVEN IF THE CANDIDATE PERFORMED THE "PUSHING" ACTIVITY AGAINST A WALL, INSTEAD OF THE BTE PRODUCT. NOTE RELATED TO (B)(4). THE HANDLES ARE MOUNTED ON THE EQUIPMENT FOR PUSH EXERCISES. THE EQUIPMENT DID NOT MALFUNCTION.

    Description of Event or Problem · 1

    JOB CANDIDATE INJURED ACHILLES TENDON DURING POST OFFER EMPLOYMENT TESTING (POET). HE WALKED OUT OF THE CLINIC ON HIS OWN BUT LIMPING AND IN PAIN. HE DECIDED TO SEEK MEDICAL ATTENTION. THE MEDICAL PLACE PUT HIS FOOT IN A BOOT TYPE BRACE AND TOLD HIM TO VISIT AN ORTHOPEDIST FOR FURTHER EXAMINATION. RESULTS OF THE ORTHOPEDIC VISIT ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033518 ER EVALUATION DEVICE IKK BTE TECHNOLOGIES ER MODEL ER

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other