BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIBBE COLON HYDROTHERAPY DEVICE

    MDR report key: 499934 · Received October 14, 2003

    Report

    Report Number
    1648139-2003-00002
    Event Type
    Other
    Date Received
    October 14, 2003
    Date of Event
    May 3, 2003
    Report Date
    October 2, 2003
    Manufacturer
    TILLER MIND BODY, INC.
    Product Code
    KPL
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    2003-MANUFACTURER STATED THERE WAS AN ALLEGED INJURY. HISTORY FORM INDICATED A HEALTH CONDITION, THAT WAS NOTED DURING USER'S SESSION WITH THE DEVICE. THE USER FACILITY NOR THE DEVICE CAUSED ANY INJURY FILE A COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBBE COLON HYDROTHERAPY DEVICE COLONIC IRRIGATION KPL TILLER MIND BODY, INC. 19703 *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization