BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERCALIGN

    MDR report key: 3786821 · Received May 2, 2014

    Report

    Report Number
    3022192-2014-00001
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    March 10, 2012
    Report Date
    February 26, 2014
    Manufacturer
    STL INTERNATIONAL, INC.
    Product Code
    HST
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN INDIVIDUAL HAS FILED A LAWSUIT CLAIMING THAT SHE WAS INJURED WHEN SHE FELL FROM AN INVERSION TABLE DUE TO HER FEET FALLING THROUGH THE ANKLE MECHANISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265573 INTERCALIGN INVERSION TABLE HST STL INTERNATIONAL, INC. IA1005

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability