LIBBE COLON HYDROTHERAPY DEVICE L9703 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2003-10-09 for LIBBE COLON HYDROTHERAPY DEVICE L9703 NA manufactured by Tiller Mind Body, Inc..

Event Text Entries

[349909] Claim of an unspecified alleged colon perforation, the end user claims to have received at a user facility. Manufacturer investigation into alleged claim, discovered device did not malfunction, is still operational and continues to operate as designed, with no further report of incidence. Device was not returned to manufacturer. Manufacturer investigated claim based on info received from physicians surgical procedure report dated 2002 that report; "in fact no obvious perforation was found. The upper rectum was opened and a procloscope inserted in an attempt to try & locate the actual injury site to be sure it was resected if possible. No clear injury was detected & no rectal injury had been detected by the examining finger". Manufacturer has been visited repeatedly by texas dept. Of health (tdh) and instructed to file and mdr. Tdh is of the opinion that device caused the alleged injury. However, tdh refuses to provide any documents of any other evidence to support their opinion, even after our repeated requests. On 8/23/03, manufacturer also requested copies through the "public info act", and offered to pay for said copies. Tdh has yet to provide the requested documents, and to date has provided no info evidencing any connection between the alleged injury or the device. On 9/16/03 another tdh visit, manufacturer reported and provided copies of surgical procedure report to tdh, that based on all info available to it, device did not cause alleged injury. However, tdh continues to insist the manufacturer file an mdr. On 9/17/03, tdh filed and faxed an e-14 insisting that manufacturer file an mdr! On 9/24/03 tdh faxed same e-14 to manufacture again. Therefore after consulting with legal council, manufacturer is filing this mdr under duress. Manufacturer reserves the right to supplement this event report with additional findings relative to the alleged injury, if any additional info becomes available in the future.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1648139-2003-00003
• MDR Report Key: 499926
• Report Source: 00,05,06
• Date Received: 2003-10-09
• Date of Report: 2003-10-07
• Date of Event: 2002-08-19
• Date Mfgr Received: 2003-05-19
• Device Manufacturer Date: 1999-12-01
• Date Added to Maude: 2003-12-11
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: ATTORNEY
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Street: 10911 WEST AVE
• Manufacturer City: SAN ANTONIO TX 78213
• Manufacturer Country: US
• Manufacturer Postal: 78213
• Manufacturer Phone: 210308888
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: LIBBE COLON HYDROTHERAPY DEVICE
• Generic Name: COLONIC IRRIGATION
• Product Code: KPL
• Date Received: 2003-10-09
• Model Number: L9703
• Catalog Number: NA
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 488693
• 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	2003-10-09