MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2003-10-14 for LIBBE COLON HYDROTHERAPY DEVICE 19703 NA manufactured by Tiller Mind Body, Inc..
[341201]
2003-manufacturer stated there was an alleged injury. History form indicated a health condition, that was noted during user's session with the device. The user facility nor the device caused any injury file a complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1648139-2003-00002 |
| MDR Report Key | 499934 |
| Report Source | 00 |
| Date Received | 2003-10-14 |
| Date of Report | 2003-10-02 |
| Date of Event | 2003-05-03 |
| 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 | 2003-10-14 |
| Model Number | 19703 |
| 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 | 488701 |
| 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 | 19703 |
| Baseline Catalog No | NA |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2003-10-14 |