BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALANCE KNEE OFM 1 IKF ADAPT

    MDR report key: 7041888 · Received November 17, 2017

    Report

    Report Number
    3006221031-2017-00002
    Event Type
    Injury
    Date Received
    November 17, 2017
    Report Date
    August 3, 2017
    Manufacturer
    OSSUR BAYREUTH
    Product Code
    ISY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LOWER LIMB AMPUTEE FELL FOUR TIMES REQUIRING A HOSPITAL VISIT. LIMITED INFORMATION AVAILABLE FROM CLINIC RELATED TO THE INCIDENT, WE ARE WORKING TO OBTAIN FURTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822961 BALANCE KNEE OFM 1 IKF ADAPT LOWER LIMB PROSTHETC ISY OSSUR BAYREUTH 1721127

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention