ANGEL OF WATER CM-1 COLON IRRIGATION SYSTEM

Description of Event or Problem

IN 2007, A FEMALE CAME TO UF FOR A COLON IRRIGATION SESSION, SOMETHING SHE HAD DONE BEFORE WITHOUT ISSUE IN THE SAME UF 3 DAYS BEFORE. PATIENT FELT CRAMPING 20 MINUTES INTO THE SESSION, WHEREBY THE HEALTH PRACTITIONER TURNED OFF THE FLOW OF WATER AND HAD THE PATIENT SLIDE OFF THE SPECULUM AND SIT IN THE BATHROOM. PATIENT COMPLAINED OF NAUSEA, WHEREBY WAS GIVEN AMMONIA INHALENT AND PROTEIN BAR AND THEN LAY ON A BIOMAT. THE PATIENT CONTINUED PALE, WEAK, DIAPHORETIC, AND SHAKY. PRACTIONER TOOK PULSE WHICH WAS 88 AND REGULAR AND THEN DID A FINGER STICK. BLOOD SUGAR WAS 145. AFTER CONFERRING TOGETHER, PATIENT AGREED THAT PRACTITIONER COULD TRANSPORT HER TO ER TEN MINUTES AWAY. PATIENT WAS ALERT, ORIENTED, AND ABLE TO AMBULATE WITHOUT DIFFICULTY THOUGH STILL PALE AND SHAKY. PATIENT VOMITED UNDIGESTED FOOD AT THE CAR AND WAS SEEN RIGHT AWAY AT ER. WAS GIVEN IV, BLOOD TAKEN. ELEVATED WBC COUNT PROMPTED CAT SCAN. PATIENT ADMITTED ON SIX DAYS LATER IN GOOD FORM AFTER ANTIBIOTICS, A SECOND CAT SCAN, NO SURGERIES.

Additional Manufacturer Narrative

BARBARA BOCK CALLED A DOCTOR ACQUAINTANCE OF HERS WHO SPOKE WITH THE TREATING PHYSICIAN. LEARNED THAT THE PATIENT HAD A RECENT COLONOSCOPY ( 3 WEEKS AGO AND NOT 3 MONTHS AGO AS INDICATED ON INTAKE FORM). WAS DIAGNOSED WITH DIVERTICULUM. THE COLONIC MAY HAVE OPENED A SMALL POCKET. DOCTOR SAID ELEVATED WBC COUNT ON ADMISSION COULD NOT HAVE BEEN CAUSED BY COLONIC IRRIGATION BUT MAY HAVE BEEN PRE-EXISTENT FROM SOME CONDITION POST-COLONOSCOPY. 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.