BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOOT ORTHOTICS

    MDR report key: 5260388 · Received November 28, 2015

    Report

    Report Number
    MW5058191
    Event Type
    Malfunction
    Date Received
    November 28, 2015
    Date of Event
    November 2, 2015
    Report Date
    November 27, 2015
    Manufacturer
    LANGER BIOMECHANICS
    Product Code
    KNP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AGGRAVATED "MENISCUS", TEAR IN LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783638 FOOT ORTHOTICS 2 FOOT INSERTS, REMOVABLE, MOLDED TO PATIENT KNP LANGER BIOMECHANICS LONGITUDINAL ARCH SUPPORT
    783639 FOOT ORTHOTICS 2 FOOT INSERTS, REMOVABLE, MOLDED TO PATIENT KNP LANGER BIOMECHANICS

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other