BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REHAB CONT AIR-LIGHT R

    MDR report key: 4237170 · Received October 30, 2014

    Report

    Report Number
    2085446-2012-00007
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    September 4, 2012
    Report Date
    October 24, 2014
    Manufacturer
    L&L INTERNATIONAL CO LTD
    Product Code
    ITQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HIGNE IS SET IN -15 DEGREES AND 105 DEGREE FLEXION. THIS INDICATES THE FULL RANGE OF MOTION OF THE BRACE HAS BEEN THE SETTING WHEN FAILED. FURTHERMORE, THE FLEXION LIMITER HAVE THE PLASTIC PLUGS IN THEM WHILE THE EXTENSION LIMITERS DON'T. THE PRODUCT IS VERY HEAVILY WORN, PADDING AND STRAPS ARE WORN A LOT. THE TWO THIGH STRAPS ARE TORN THROUGH THE ULTRASONIC WELD OF THE HOOK PART TO THE STRAP. TOP STRAP HAS DELAMINATED THROUGH HIGH LOADING AS THE FIBRES IN THE STRAP INDICATED. THE LOWER THIGH STRAP HAS TORN AND DELAMINATED, PROBABLY AT LOWER THIGH STRAP HAS TORN AND DELAMINATED, PROBABLY AT THE SAME TIME. THERE STRAPS SHOULD NOT GIVE IN UNDER THESE LOADINGS AND ESPECIALLY AT THE SETTINGS GIVEN IN THE BRACE. THE FLEXION AND EXTENSION LIMITERS ARE INTACT AND SHOW NO SIGN OF FAILURE. NO SIGN OF HIGH LOADING CAN BEN SEEN ON THE HINGE CENTER. THE MARKS THERE ARE MORE AS A SIGN OF NORMAL WEAR AND TEAR. IT WOULD SEEM VERY UNLIKELY THAT THE UNIT WOULD FAIL DRASTICALLY UNLESS THE USER TRIPPED OR OTHERWISE WAS IN ABNORMAL CONDITIONS BASED ON THE ASSESSMENT OF THE BRACE.

    Description of Event or Problem · 1

    THE PT WAS WEARING THE REHAB KNEE BRACE WHILE WALKING UP A FLIGHT OF STAIRS. THE PT CLAIMS THE VELCRO ON THE BRACE FAILED CAUSING HIM TO FALL. HE WAS ABLE TO CATCH AND BRACE HIMSELF BUT HE LANDED ON HIS KNEE AND FRACTURED HIS PATELLA. HE WENT IN FOR SURGERY THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695121 REHAB CONT AIR-LIGHT R JOINT, KNEE, EXTERNAL BRACE ITQ L&L INTERNATIONAL CO LTD B-220500000

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization