LIBBE COLON HYDROTHERAPY DEVICE
Received Oct 9, 2003 · Event occurred Mar 5, 2003
Report 1648139-2003-00001 · MDR key 499946
Device
Generic name
Colonic Irrigation
Manufacturer
Tiller Mind Body, Inc.Model number
L9703Catalog number
NA
Lot number
*
Product problems
- Unknown (for use when the device problem is not known)
Patient
37 YR
- Injury
Narrative
Description of Event or Problem
2003 - MANUFACTURER STATING THAT A COMPLAINT HAD BEEN FILED FOR AN ALLEGED INJURY. MANUFACTURER HAS NO KNOWLEDGE OF ANY INJURY! MANFACTURER INVESTIGATION INTO ALLEGED CLAIM, DISCOVERED DEVICE DID NOT MALFUNCTION, IS STILL OPERATION AND CONTINUES TO OPERATE AS DESIGNED WITH NOT FURTHER REPORT OF INCIDENCE. DEVICE WAS NOT RETURNED TO MANUFACTURE. HOWEVER, REFUSES TO PROVIDE ANY DOCUMENTS. OR ANY OTHER EVIDENCE TO SUPPORT THEIR OPINION, EVEN AFTER OUR REPEATED REQUESTS. ON 8/23/03, MANUFACTURER ALSO REQUESTED ALL DOCUMENTS THROUGH THE "PUBLIC INFO ACT" AND OFFERED TO PAY FOR SAID COPIES. TDH CONTINUES TO INSIST THE MANUFACTURER FILE AND MDR. THEREFORE DESPITE NO EVIDENCE LINKING THE ALLEGED INJURY TO TO THE DEVICE, MANUFACTURER SUBMITS THIS MDR UNDER DURESS. MANUFACTURER RESERVES THE RIGHT TO SUPPLEMENT THIS EVENT REPORT WITH ADDITIONAL FINDINGS RELATIVE TO THE ALLEGED INJURY, IF ANY ADDITIONAL FINDINGS RELATIVE TO THE ALLEGED INJURY, IF ANY ADDITIONAL INFO BECOMES AVAILABLE IN THE FUTURE.