JIMMY JOHN III NOZZLE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-05-08 for JIMMY JOHN III NOZZLE * manufactured by Colon Therapeutics, Inc..

Event Text Entries

[332519] In 2002, patient received a colon hydrotherapy. At the end of the procedure, patient was checked and denied any adversed reactions or problems. First notice of any problems or reactions was received after a threat of litigation 5 mos later. Pt's attorney alleged that their sigmoid colon was punctured by a plastic rectal nozzle that was attached to the jimmy john iii colon irrigation device. This is a description of the allegations by pt's attorney. These statements nor anything else on this form are an admission of liability for pt's injury and subsequent death. Liability is expressly denied.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	461147
MDR Report Key	461147
Date Received	2003-05-08
Date of Report	2003-05-06
Date of Event	2002-04-21
Date Facility Aware	2002-09-05
Report Date	2003-05-06
Date Reported to Mfgr	2002-09-08
Date Added to Maude	2003-05-22
Event Key	0
Report Source Code	User Facility report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	0
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	3
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	JIMMY JOHN III NOZZLE
Generic Name	COLON IRRIGATION DEVICE
Product Code	KDH
Date Received	2003-05-08
Model Number	JIMMY JOHN III
Catalog Number	*
Lot Number	*
ID Number	*
Operator	OTHER
Device Availability	N
Device Age	2 YR
Implant Flag	N
Date Removed	*
Device Sequence No	1
Device Event Key	450089
Manufacturer	COLON THERAPEUTICS, INC.
Manufacturer Address	2909 MAIN GROVES TX 77619 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2003-05-08