BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BODY WEIGHT SUPPORT LIGHT

    MDR report key: 17433390 · Received August 1, 2023

    Report

    Report Number
    3006750942-2023-00001
    Event Type
    Malfunction
    Date Received
    August 1, 2023
    Date of Event
    July 25, 2023
    Report Date
    August 1, 2023
    Manufacturer
    MOTEK MEDICAL B.V.
    Product Code
    BXB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT DURING TREATMENT, THE PATIENT ROLLED ANKLE ON AFFECTED LE. PT WAS PRACTICING AMBULATION W/OP AFO. TREADMILL SPEED WAS ASSESSING AND SLOWER THAN NORMAL TO ACCOMMODATE WALKING SANS BRACING. DUE TO ROLLED ANKLE, PATIENT TRIPPED AND FELL UPON HARNESS SAFETY STRAP FAILING. ALLEGEDLY, THE STITCHING ON THE HARNESS BUCKLE ATTACHING TO THE OVERHEAD BODY WEIGHT SUPPORT POPPED ALL THE WAY THROUGH ALLOWING THE STRAP TO COME APART AND SLIDE THROUGH THE SUPPORTING CARABINER. CUSTOMER REPORTED THAT THE EMERGENCY STOP WAS IMMEDIATELY PRESSED HALTING THE TREADMILL. CUSTOMER REPORTED THAT PT WAS IMMEDIATELY ASSESSED, NO REPORTS OF PAIN AND NO VISIBLE INJURIES. MEASURES WERE TAKEN FOR SOFT TISSUE INJURIES TO LE. NO MEDICAL MEASURES WERE NEEDED AND PT WAS ABLE TO CONTINUE THERAPY AS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1635465 BODY WEIGHT SUPPORT LIGHT POWERED EXERCISER BXB MOTEK MEDICAL B.V. RB011

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown