MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2003-10-09 for LIBBE COLON HYDROTHERAPY DEVICE L9703 NA manufactured by Tiller Mind Body, Inc..
[341203]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1648139-2003-00001 |
| MDR Report Key | 499946 |
| Report Source | 00,06 |
| Date Received | 2003-10-09 |
| Date of Report | 2003-10-07 |
| Date of Event | 2003-03-05 |
| Date Mfgr Received | 2003-08-26 |
| Device Manufacturer Date | 1999-01-01 |
| 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 |
| 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 | 2103088888 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| 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 | 488713 |
| 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 | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-10-09 |