LIBBE L9703 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-10-07 for LIBBE L9703 * manufactured by Tiller Mind Body, Inc..

Event Text Entries

[355039] Client came for colon hydrotherapy, during procedure complained of cramps. For some people having cramps is a normal occurrence as part of having colon hydrotherapy. However, the client requested an ambulance due to the cramping. The ambulance driver upon arrival asked if there was any bleeding, one ambulance driver and rep checked the table and the toilet, there was no blood. Later same night and the next two days rep inquired in the hospitals, also, made several attempts to call patient and never got any answer. The next contact rep had was in 09/2002, when their family member called to inquire if rep had any liability insurance to which rep answered, yes. Rep recently learned during their deposition that patient went a week later after the incident to have a surgery. However, rep was aware of this now, but rep has not seen patient medical records.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 522644
• MDR Report Key: 522644
• Date Received: 2003-10-07
• Date of Report: 2003-10-07
• Date of Event: 2002-08-19
• Date Facility Aware: 2002-08-19
• Report Date: 2003-10-07
• Date Reported to Mfgr: 2002-08-20
• Date Added to Maude: 2004-04-30
• 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: 3
• 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: LIBBE
• Generic Name: LOWER BOWEL EVACUATION DEVICE
• Product Code: KPL
• Date Received: 2003-10-07
• Model Number: L9703
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: OTHER
• Device Availability: Y
• Device Age: 6 YR
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 511772
• Manufacturer: TILLER MIND BODY, INC.
• Manufacturer Address: 10911 WEST AVE SAN ANTONIO TX 78213 US
• Baseline Brand Name: LIBBE COLON HYDROTHERAPY DEVICE
• Baseline Generic Name: COLONIC IRRIGATION
• Baseline Model No: L9703
• Baseline Catalog No: NA
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2003-10-07