ANGEL OF WATER CM-1 COLON IRRIGATION SYSTEM

Description of Event or Problem

PT RECEIVED A COLONIC ON (B)(6) 2010 AT USER FACILITY. SHE ARRIVED AT 7:00 FOR A SIXTH VISIT TO THE CLINIC OVER A PERIOD OF FOUR MONTHS AND WAS FAMILIAR AND COMFORTABLE WITH THE PROCESS. THE SESSION WAS NORMAL WITH LARGE AMOUNTS OF WASTE MATERIAL BEING PASSED. PATIENT'S SESSION LASTED ONE HOUR, AFTER WHICH SHE REMARKED SHE WAS PLEASED WITH THE SESSION. SHE LEFT COMPOSED, OF HER OWN ACCORD, STATING THAT SHE WAS GLAD SHE HAD COME IN. USER FACILITY RECEIVED A CALL FROM A DOCTOR AT A NEARBY HOSPITAL 3 DAYS LATER, (B)(6), WHO IDENTIFIED HIMSELF BUT BRIEFLY, SAID HE HAD A PT WITH A PERFORATED COLON, AND ASKED SEVERAL QUESTIONS ABOUT THE PROCEDURE AND EQUIPMENT. THE USER FACILITY OWNER ANSWERED HIS QUESTIONS, TO WHICH HE REPLIED "INTERESTING, VERY INTERESTING." HE THEN ABRUPTLY HUNG UP THE PHONE BEFORE THE PRACTITIONER COULD ASK HIM TO REPEAT HIS NAME OR FURTHER IDENTIFY HIMSELF BUT HE DID IDENTIFY THE PT AS (B)(6). USER FACILITY RECEIVED AN UNCERTIFIED LEGAL LETTER ON 7.27.2010 SEEKING DAMAGES FOR PT HOSPITALIZATION ON (B)(6) 2010 AND A DIAGNOSIS OF "PUNCTURED COLON." THE HOSPITAL STAY PURPORTEDLY LASTED FIVE DAYS BUT THERE WAS NO INDICATION OF WHAT TREATMENT THE PT RECEIVED.

Additional Manufacturer Narrative

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.