OtherKPL
ANGEL OF WATER COLON IRRIGATION SYSTEM
Received Dec 23, 2010 · Event occurred Dec 15, 2010
Report 3003860916-2010-00002 · MDR key 2948251
Device
Product problems
- Insufficient Device Problem Information
Patient
33 YR
- Nausea
- Cramp(s)
Narrative
Description of Event or Problem
FEMALE PT WAS DRIVEN TO THE ER IN PRIVATE CAR AFTER FEELING OF CRAMPING AND NAUSEA DURING COLON HYDROTHERAPY SESSION. PT WAS CHECKED OUT AT ER BY ATTENDING NURSE/PHYSICIAN BUT NOT ADMITTED TO THE HOSPITAL. NO TREATMENT WAS GIVEN. PT REPORTED THAT EVENING LATE THAT THEY WERE "FEELING BETTER."
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 DVICE THAT IS PART OF THE ANGEL OF WATER COLON IRRIGATION SYSTEM.