ANGEL OF WATER CM-1 COLON IRRIGATION SYSTEM
Received Jan 3, 2017 · Event occurred May 6, 2016
Report 3003860916-2016-00001 · MDR key 6219849
Device
Generic name
Colon Irrigation Equipment
Manufacturer
Lifestream Purification Systems, LlcModel number
CM-1Catalog number
CM-1
Lot number
N/A
Product problems
- Device Issue
- Missing Value Reason
- Device Issue
- Missing Value Reason
Patient
Not reported
- Perforation
- Injury
- Bowel Perforation
- Patient Problem/Medical Problem
- Perforation
- Injury
- Bowel Perforation
- Patient Problem/Medical Problem
Narrative
Additional Manufacturer Narrative
VERY LITTLE DATA IS CURRENTLY AVAILABLE TO LIFESTREAM. NOTICE FROM (B)(6) WAS RECEIVED ON DECEMBER 3, 2016 AND AN INVESTIGATION HAS COMMENCED. NO OTHER DATA, OTHER THAN THE ONE SENTENCE PROVIDED BY THE (B)(6), IS KNOWN AT THIS TIME.
Description of Event or Problem
ON 12/03/2016, A LETTER WAS RECEIVED FROM THE (B)(6), THAT AN INCIDENT INVOLVING THE AOW CM-1 DEVICE HAD TAKEN PLACE IN (B)(6) ON (B)(6) 2016. THE SPECIFIC WORDING OF THE INCIDENT IS AS FOLLOWS: "CLINICAL EVENT INFORMATION: FOLLOWING THE TREATMENT (WHICH WAS SELF-ADMINISTERED AND WITHOUT SUPERVISION) THE COMPLAINANT WAS IN IMMEDIATE PAIN AND SUBSEQUENTLY SUFFERED A PERFORATED BOWEL." PRIOR TO THIS LETTER FROM THE (B)(6), NO NOTICE WAS RECEIVED BY LIFESTREAM FROM A USER FACILITY OR THE COMPLAINANT OF THE INCIDENT.