BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX-RUN WITH NIKE SOLE

    MDR report key: 11054853 · Received December 22, 2020

    Report

    Report Number
    3003764610-2020-00002
    Event Type
    Malfunction
    Date Received
    December 22, 2020
    Date of Event
    November 2, 2020
    Report Date
    December 22, 2020
    Manufacturer
    OSSUR HF
    Product Code
    ISH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PRODUCT FAILED TO PROVIDE SUPPORT WHEN CARBON BLADE BROKE BY BRITTLE FAILURE WHEN USER (SPORT ATHLETE) WAS SPRINTING AT APPROX 20 MPH, CAUSING HIM TO FALL. THE USER IS A SPORTS ATHLETE WITH IMPACT LEVEL EXTREME AND ACTIVITY LEVEL VERY HIGH. HE SUSTAINED A CONCUSSION AND WAS OFF TRAINING FOR A WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1524704 FLEX-RUN WITH NIKE SOLE PROSTHETIC FOOT ISH OSSUR HF

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other