BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARMEDICA HI-LO TREATMENT TABLE

    MDR report key: 4132582 · Received September 24, 2014

    Report

    Report Number
    1649977-2014-00001
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 18, 2014
    Manufacturer
    ARMEDICA MFG. CORP.
    Product Code
    INQ
    PMA / PMN Number
    K981539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CLINIC EMPLOYEES DAUGHTER INADVERTENTLY RESTED HER FOOT ON MOTOR CONTROL CAUSING TABLE TO LOWER PINNING (AND BREAKING) BONE IN HER LEG. THE INJURY NOT OCCUR DURING USE. INJURY WAS DUE TO NON-CLINICAL PERSONNEL ACCIDENTALLY ACTIVATING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593661 ARMEDICA HI-LO TREATMENT TABLE HI-LO TREATMENT TABLE INQ ARMEDICA MFG. CORP. AM-BA350 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R