BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX-RUN WITH NIKE SOLE

    MDR report key: 8621621 · Received May 17, 2019

    Report

    Report Number
    3003764610-2019-00007
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Report Date
    May 17, 2019
    Manufacturer
    OSSUR HF
    Product Code
    ISH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO FALL/INCIDENT NOR INJURY OCCURRED DUE TO THE REPORTED FAILURE. GIVEN THE INTENDED USE (RUNNING, SPORTS ACTIVITIES) OF THE PRODUCT, THERE IS A RISK FOR ISSUE LEADING TO INJURY WHEN FAILURE WOULD OCCUR DURING USE. THEREFORE WE SEND IN THIS VIGILANCE REPORT. OSSUR IS HOWEVER NOT AWARE THAT THE DESCRIBED FAILURE TYPE FOR THIS PROSTHETIC FOOT EVER LED TO INJURY. (B)(4).

    Description of Event or Problem · 1

    DEVICE BROKE SUDDENLY DURING TRAINING. NO INJURIES OCCURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415334 FLEX-RUN WITH NIKE SOLE PROSTHETIC FOOT ISH OSSUR HF FSX0087LO

    Patients

    Seq Age Sex Outcome Treatment
    1