BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIBBE COLON HYDROTHERAPY DEVICE

    MDR report key: 499946 · Received October 9, 2003

    Report

    Report Number
    1648139-2003-00001
    Event Type
    Other
    Date Received
    October 9, 2003
    Date of Event
    March 5, 2003
    Report Date
    October 7, 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 STATING THAT A COMPLAINT HAD BEEN FILED FOR AN ALLEGED INJURY. MANUFACTURER HAS NO KNOWLEDGE OF ANY INJURY! MANFACTURER INVESTIGATION INTO ALLEGED CLAIM, DISCOVERED DEVICE DID NOT MALFUNCTION, IS STILL OPERATION AND CONTINUES TO OPERATE AS DESIGNED WITH NOT FURTHER REPORT OF INCIDENCE. DEVICE WAS NOT RETURNED TO MANUFACTURE. HOWEVER, REFUSES TO PROVIDE ANY DOCUMENTS. OR ANY OTHER EVIDENCE TO SUPPORT THEIR OPINION, EVEN AFTER OUR REPEATED REQUESTS. ON 8/23/03, MANUFACTURER ALSO REQUESTED ALL DOCUMENTS THROUGH THE "PUBLIC INFO ACT" AND OFFERED TO PAY FOR SAID COPIES. TDH CONTINUES TO INSIST THE MANUFACTURER FILE AND MDR. THEREFORE DESPITE NO EVIDENCE LINKING THE ALLEGED INJURY TO TO THE DEVICE, MANUFACTURER SUBMITS THIS MDR UNDER DURESS. MANUFACTURER RESERVES THE RIGHT TO SUPPLEMENT THIS EVENT REPORT WITH ADDITIONAL FINDINGS RELATIVE TO THE ALLEGED INJURY, IF ANY ADDITIONAL FINDINGS RELATIVE TO THE ALLEGED INJURY, IF ANY ADDITIONAL INFO BECOMES AVAILABLE IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBBE COLON HYDROTHERAPY DEVICE COLONIC IRRIGATION KPL TILLER MIND BODY, INC. L9703 *

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other