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Adverse Event Report

COLON THERAPEUTICS, INC. JIMMY JOHN III NOZZLE COLON IRRIGATION DEVICE   back to search results
Model Number JIMMY JOHN III
Event Date 04/21/2002
Patient Outcome  Death;
Event Description

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.

 
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Brand NameJIMMY JOHN III NOZZLE
Type of DeviceCOLON IRRIGATION DEVICE
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
COLON THERAPEUTICS, INC.
2909 main
groves TX 77619
Manufacturer (Section D)
COLON THERAPEUTICS, INC.
2909 main
groves TX 77619
Device Event Key450089
MDR Report Key461147
Event Key436895
Report Number461147
Device Sequence Number1
Product CodeKDH
Report Source User Facility
Reporter Occupation Invalid Data
Type of Report Initial
Report Date 05/06/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/08/2003
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Other
Device MODEL NumberJIMMY JOHN III
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date09/05/2002
Device Age2 yr
Event Location Other
Date Report TO Manufacturer09/08/2002
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Patient TREATMENT DATA
Date Received: 05/08/2003 Patient Sequence Number: 1
#TreatmentTreatment Date
1,THE NOZZLE WAS DISPOSED OF AND JIMMY JOHN III,
2,DEVICE IS AVAILABLE FOR EVALUATION.,

Database last updated on January 30, 2009

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