LIBBE COLONIC DEVICE L9703 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-08-28 for LIBBE COLONIC DEVICE L9703 * manufactured by Tiller Mind Body.

Event Text Entries

[18607317] Pt arrived for a colonic along with three other friends. Reporter instructed pt on the colonic procedure, and how the procedure works. After they were properly instructed on how to insert the rectal tubing, how to properly lay on the table, and how to start the flow of the water into the colon reporter advised pt to call them by ringing a buzzer that is placed on a table next to the colonic table if they were having any problems. Reporter also told pt that reporter would return regardless in 10 minutes. Pt proceeded with starting their colonic and reporter checked on pt within the first 10 minutes of the procedure. They said they were fine, they were just cramping a little. An employee checked on pt after another 10-15 minutes. Again they said they were fine. At the end of the colonic session pt was instructed to drain on the table and then to go into the bathroom to wash up. After pt's colonic they returned to the waiting area exhibiting discomfort. They said they felt as if they had a gas pocket that they couldn't pass. They went back into the bathroom but returned saying they did not pass the gas pocket nor any waste. They did not mention passing any blood at all, nor did rptr see any while they were on the table. They did seem to be in quite a bit of discomfort. Facility offered to call their doctor, or to call 911. They refused the offer saying they would be alright. Pt left with their friends. Facility heard later from their friends that they had gone to the emergency room a week later for treatment for a urinary tract infection. A week or so later another client reported to rptr when they came in for a colonic that pt had been hospitalized for a boil or cyst in their retum area. Pt never followed up with reporter. Facility called their home the week that facility was told that they were in the hospital. Whoever answered the phone said that they were unavailable. Facility received a certified letter from their attorney dated 2003. Rptr immediately called facility to notify them of the letter and they told reporter to call their insurance company. Insurance co contacted pt's law firm in 2003 requesting medical reports and all necessary info to investigate the claim. Pt's attorneys did not respond at all until two months later with a letter indicating that pt had been hospitalized. No additional info was reported to the insurance company. Pt's attorney to this date has not responded with the necessary info regarding their claim.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1029421
MDR Report Key482605
Date Received2003-08-28
Date of Report2003-08-28
Date of Event2003-03-05
Date Added to Maude2003-09-11
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameLIBBE COLONIC DEVICE
Generic NameCOLON HYDROTHERAPY
Product CodeKPL
Date Received2003-08-28
Model NumberL9703
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key471494
ManufacturerTILLER MIND BODY
Manufacturer Address10911 WEST AVENUE SAN ANTONIO TX 782131537 US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2003-08-28

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