MAUDE MDR 2190164

MDR report key
2190164
Report number
3003860916-2007-00001
Event key
0
Event type
3
Date of event
2007-01-08
Date received
2007-03-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
2001 S. LAMAR BLVD. STE. G AUSTIN TX 78704 US
Phone
512-512-5127
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ANGEL OF WATER CM-1 COLON IRRIGATION SYSTEM78 KPLLIFESTREAM PURIFICATION SYSTEMS, LLCKPLCM-1NAR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-03-0701. R

Event Narratives#

D

Patient 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.

N

Patient 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.