JIMMY JOHN III
Received Oct 28, 2003 · Event occurred Dec 13, 2001
Report 1640200-2003-00003 · MDR key 493975
Device
Generic name
Colonic Enema Device
Manufacturer
Colon Therapeutics Inc.Model number
2-CCatalog number
*
Lot number
*
Product problems
- Unknown (for use when the device problem is not known)
Patient
UNKNOWN
- Perforation
Narrative
Description of Event or Problem
CLAIM OF AN UNSPECIFIED ALLEGED COLON PERFORATION THE END USER CLAIMS TO HAVE RECEIVED AT AN USER FACILITY. MANUFACTURER INVESTIGATION INTO THE ALLEGED CLAIM, DISCOVERED DEVICE DID NOT MALFUNCTION, IS STILL OPERATIONAL AND CONTINUES TO OPERATE AS INTENDED AND DESIGNED, WITH NO FURTHER REPORT OF INCIDENCE. DEVICE IN QUESTION WAS NOT RETURNED TO MANUFACTURER. MANUFACTURER HAS REQUESTED MORE INFORMATION INTO THE ALLEGED PERFORATION AND EVIDENCE INTO THE ALLEGED PERFORATION BEING CAUSED BY THE COLONIC DEVICE, BUT TO DATE NONE HAS BEEN PROVIDED SUCH AS TYPE OF COLON SCOPE USED, ACTUAL MEDICAL HISTORY OF THE USER, MEDICAL REPORTS OF ALLEGED PERFORATION AND CAUSE, ETC.