MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-01-25 for LIBBE 9703 manufactured by Tiller Mind Body, Inc..
[3238671]
(b)(6) presented for a colon hydrotherapy session and complained of discomfort after insertion and before starting the therapy session. (b)(6) insisted on doing the therapy session. (b)(6) complained of discomfort two or three times during the session. The therapist told (b)(6) to stop and cease the therapy session several times, but (b)(6) refused to terminate the therapy session. (b)(6) completed the therapy session, then complained of burning in anus. Any alleged injuries are unverified. We are now attempting to obtain info about the event.
Patient Sequence No: 1, Text Type: D, B5
[10448535]
We are attempting to obtain more info about the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1648139-2013-00001 |
| MDR Report Key | 2934632 |
| Report Source | 06 |
| Date Received | 2013-01-25 |
| Date of Report | 2013-01-21 |
| Date of Event | 2011-03-07 |
| Date Mfgr Received | 2013-01-11 |
| Device Manufacturer Date | 2005-08-26 |
| Date Added to Maude | 2013-02-22 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 10911 WEST AVE. |
| Manufacturer City | SAN ANTONIO TX 78213 |
| Manufacturer Country | US |
| Manufacturer Postal | 78213 |
| Manufacturer Phone | 2103088888 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIBBE |
| Generic Name | COLONIC IRRIGATION SYSTEM |
| Product Code | KPL |
| Date Received | 2013-01-25 |
| Model Number | 9703 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TILLER MIND BODY, INC. |
| Manufacturer Address | SAN ANTONIO TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-25 |