BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIBBE

    MDR report key: 2934632 · Received January 25, 2013

    Report

    Report Number
    1648139-2013-00001
    Event Type
    Other
    Date Received
    January 25, 2013
    Date of Event
    March 7, 2011
    Report Date
    January 21, 2013
    Manufacturer
    TILLER MIND BODY, INC.
    Product Code
    KPL
    PMA / PMN Number
    K941279
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE ATTEMPTING TO OBTAIN MORE INFO ABOUT THE EVENT.

    Description of Event or Problem · 1

    (B)(6) PRESENTED FOR A COLON HYDROTHERAPY SESSION AND COMPLAINED OF DISCOMFORT AFTER INSERTION AND BEFORE STARTING THE THERAPY SESSION. (B)(6) INSISTED ON DOING THE THERAPY SESSION. (B)(6) COMPLAINED OF DISCOMFORT TWO OR THREE TIMES DURING THE SESSION. THE THERAPIST TOLD (B)(6) TO STOP AND CEASE THE THERAPY SESSION SEVERAL TIMES, BUT (B)(6) REFUSED TO TERMINATE THE THERAPY SESSION. (B)(6) COMPLETED THE THERAPY SESSION, THEN COMPLAINED OF BURNING IN ANUS. ANY ALLEGED INJURIES ARE UNVERIFIED. WE ARE NOW ATTEMPTING TO OBTAIN INFO ABOUT THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36075 LIBBE COLONIC IRRIGATION SYSTEM KPL TILLER MIND BODY, INC. 9703

    Patients

    Seq Age Sex Outcome Treatment
    1