BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGEL OF WATER CM-1 COLON IRRIGATION SYSTEM

    MDR report key: 2190164 · Received March 7, 2007

    Report

    Report Number
    3003860916-2007-00001
    Event Type
    Injury
    Date Received
    March 7, 2007
    Date of Event
    January 8, 2007
    Report Date
    February 20, 2007
    Manufacturer
    LIFESTREAM PURIFICATION SYSTEMS, LLC
    Product Code
    KPL
    PMA / PMN Number
    K003720
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2007, MORE THAN A MONTH AFTER THE PT VISITED THE (B)(6), THE HEALTH PRACTITIONER RECEIVED A LETTER FROM A PERSONAL INJURY ATTORNEY ALLEGING THAT DURING THE COLON IRRIGATION SESSION ON (B)(6) 2007 [SIC], THE PT'S COLON WAS PUNCTURED. THE LETTER FURTHER ALLEGED THAT THE PT UNDERWENT REPARATIVE SURGERY, NOW HAS A TEMPORARY COLOSTOMY BAG, AND WILL NEED A SECOND SURGERY. THE PART OF THE DEVICE REFERRED TO UNDER "USAGE OF DEVICE" IS THE ANGEL OF WATER DISPOSABLE RECTAL NOZZLE, A STERILE, SINGLE USE DEVICE THAT IS PART OF THE ANGEL OF WATER COLON IRRIGATION SYSTEM, WHICH IS REUSABLE. THE UF DISPOSED OF THE USED RECTAL NOZZLE, LINENS, ETC IN THE NORMAL WAY OF DISPOSING OF MEDICAL WASTE. THERE WAS NO EVIDENCE OR BLOOD OR OTHER ABNORMALITY IN THE IRRIGATION ROOM, ON THE SUPPLIES, OR IN THE REST ROOM USED BY THE PT.

    Description of Event or Problem · 1

    ON (B)(6) 2007, A (B)(6) FEMALE CAME TO UF FOR A COLON IRRIGATION SESSION, SOMETHING SHE HAD EXPERIENCED BEFORE. SHE FILLED OUT INTAKE AND CONSENT FORMS, WENT THROUGH AN ORIENTATION, AND COMMENCED A NORMAL SESSION. PT FELT CRAMPING A FEW MOMENTS INTO THE SESSION, WHEREBY THE HEALTH PRACTITIONER TURNED OFF THE FLOW OF WATER AND HAD THE PT SLIDE OFF THE NOZZLE. AFTER SPEAKING TOGETHER A FEW MOMENTS, THE PT DECIDED TO HAVE THE WATER TURNED ON AGAIN AND TOOK 3-5 GALLONS OF WATER, AFTER WHICH THE PRACTITIONER AGAIN STOPPED THE FLOW OF WATER DUE TO CONTINUED CRAMPING. THIS HAPPENED A THIRD TIME AND BOTH PATIENT AND PRACTITIONER AGREED TO STOP THE SESSION, THOUGH SOME CRAMPING IS WELL WITHIN THE RANGE OF A NORMAL SESSION IF A PERSON HAS BEEN HAVING DIFFICULTY WITH THEIR DIGESTION OR ELIMINATION. PT STAYED BY HERSELF IN THE ROOM FOR A FEW MINUTES TO REDRESS AND THEN SPENT 20 MINUTES TALKING WITH PRACTITIONER IN CHECK-OUT AREA BEFORE USING THE REST ROOM, PAYING, DISCUSSING RESCHEDULING, AND TAKING LEAVE. THE PT REPORTED NO PAIN AND LEFT THE CLINIC OF HER OWN ACCORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGEL OF WATER CM-1 COLON IRRIGATION SYSTEM 78 KPL KPL LIFESTREAM PURIFICATION SYSTEMS, LLC CM-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention