BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREE WALK

    MDR report key: 9784821 · Received March 4, 2020

    Report

    Report Number
    9616494-2019-00001
    Event Type
    Injury
    Date Received
    March 4, 2020
    Date of Event
    October 15, 2019
    Report Date
    November 15, 2019
    Manufacturer
    OTTOBOCK SE & CO KGAA
    Product Code
    ITQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO OUR EVALUATION WE ASSUME THAT THE FAILURE OF THE PRODUCT WAS RELATED TO THE CONDITIONS THE PATIENT USES ITS DEVICE. THE ENVIRONMENTAL SURROUNDINGS (FOREST, WOOD LOGS, UNEVEN GROUND, EXCESSIVE USAGE OF THE PRODUCT (5-7MILES/DAY) MIGHT HAVE ALSO INCREASED THE WEAR OF THE PRODUCT. OUR EVALUATION SHOWS THAT THE PRODUCT WAS IN ACCORDANCE TO ITS SPECIFICATIONS.

    Description of Event or Problem · 1

    WE RECEIVED AN ORTHOSIS FROM THE PATIENT SHOWING A BROKEN FOOT BAR, RIGHT BELOW THE ORTHOTIC ANKLE JOINT. WE ASSUME THAT PATIENT STUMBLED WHAT RESULTED IN A FALL. DUE TO THE FALL THE PATIENT BROKE THREE RIBS. THE PATIENT IS HOMELESS BY CHOICE AND LIVES OUTSIDE IN THE WOODS. HE WALKS WITH THE ORTHOSIS 4-7 MILES/DAY ON UNEVEN TERRAIN, HILLS AND FALLEN LOGS. PATIENT FIND HIS ORTHOSIS EXTREMELY USEFUL UNTIL IT BREAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247821 FREE WALK 170K1 ITQ OTTOBOCK SE & CO KGAA 170K1

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other