ANGEL OF WATER CM-1 COLON IRRIGATION SYSTEM

Description of Event or Problem

A (B)(6) FEMALE PATIENT WITH NO CONTRAINDICATIONS FOR COLON HYDROTHERAPY WAS REFERRED TO (B)(6) BY A PHYSICIAN. SHE COMPLAINED OF A SHARP PAIN IN LOWER ABDOMEN 5 MINUTES AFTER COMMENCING HER COLON HYDROTHERAPY SESSION. SESSION WAS IMMEDIATELY STOPPED, PATIENT CONTINUED TO CRY OUT LOUDLY AND EMS TRANSPORT WAS OFFERED. PATIENT REFUSED TRANSPORT ASKING TO SEE DR. (B)(6), MD, MEDICAL DIRECTOR OF THE SPA. DR. (B)(6) ARRIVED AT PATIENT'S SIDE WITHIN TEN MINUTES AND HER EXAM SHOWED NOTHING. PATIENT CONTINUED TO CRY OUT LOUDLY AND EMS WAS CALLED. EMS FOUND NOTHING AND PATIENT WAS TAKEN TO HOSPITAL AND ADMITTED. "ROGRAFIA" (RADIOGRAPHY) WAS CONDUCTED AND SURGICAL TEAM BROUGHT IN TO EXAMINE PATIENT AND ALL FOUND NOTHING. PHYSICIANS RECOMMENDED DISCHARGE AND FOLLOW-UP GENERAL CHECKUP. PATIENT WAS DISCHARGED ON SAME DAY OF EVENT, (B)(6) 2006, BUT REFUSED MEDICAL FINDINGS AND SUGGESTION OF GENERAL CHECK UP. PATIENT'S MANNER WAS CONTRARY AND SHE APPEARED UPSET THAT SHE HAD BEEN CLEARED TO LEAVE. USER FACILITY COMMENTED THAT THEY SUSPECTED SHE MIGHT BE A "PROVOCATEUR."

Additional Manufacturer Narrative

PATIENT WAS ADMITTED TO HOSPITAL ON DAY OF EVENT (B)(6) 2006 AND DISCHARGED THE SAME DAY, A FRIDAY. ON MONDAY, PATIENT CHECKED HERSELF INTO NEPHROLOGY WARD OF A SECOND HOSPITAL COMPLAINING OF "INTESTINAL" PAIN, WHERE AGAIN, NO MEDICAL DIAGNOSIS WAS GIVEN FOR HER PROBLEM. SHE WAS TRANSFERRED TO SURGICAL WARD ON (B)(6) AND STAYED THERE UNTIL (B)(6) UNDERGOING A COLONOSCOPY AND OTHER DIAGNOSTIC TESTS. PATIENT COMPLAINED CONSTANTLY OF WHAT WAS TRANSLATED AS "INTESTINAL INTERWEAVE" OR "PUNCH" FOR WHICH NO MEDICAL EVIDENCE WAS FOUND OR CHARTED FOR. DOCTORS IN BOTH HOSPITALS FAILED TO FIND EVIDENCE OF COLON PERFORATION OR ANY OTHER PATHOLOGICAL CONDITION. DOCTORS GAVE UF STAFF ASSURANCE THAT THEY HAD OBSERVED DUE DILIGENCE IN THEIR IMMEDIATE CARE OF PATIENT. PATIENT CONTINUED TO INSIST THAT HER CARE AT THE SPA WAS FAULTY. UF NOTED THAT PATIENT ABANDONED COMPLAINT AFTER PATIENT'S HUSBAND ATTEMPTED TO BLACKMAIL (CALLED AND DEMANDED MONEY FROM) THE MEDICAL DIRECTOR OF THE UF, DR. (B)(6), MD. DR. (B)(6) REFUSED THE MAN'S DEMANDS. USER FACILITY SUSPECTED A "SHAM" EVENT FROM POSSIBLE COMPETITORS FOR THE ENTIRE INCIDENT. MFR. IS REPORTING THIS EVENT AS "OTHER" AS WE ARE REQUIRED TO REPORT EVENTS RESULTING IN EMS TRANSPORT DIRECTLY FROM UF LEADING TO HOSPITALIZATION. (B)(6).